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Coordinates patient scheduling, registration, insurance and financial inquiries while providing customer service and maintaining accurate confidential records.
At Northwestern Medicine, every patient interaction makes a difference in cultivating a positive workplace. This patient-first approach is what sets us apart as a leader in the healthcare industry. As an integral part of our team, you’ll have the opportunity to join our quest for better health care, no matter where you work within the Northwestern Medicine system. We pride ourselves on providing competitive benefits: from tuition reimbursement and loan forgiveness to 401(k) matching and lifecycle benefits, our goal is to take care of our employees. Ready to join our quest for better?
The Patient Access Specialist reflects the mission, vision, and values of NMHC, adheres to the organizations Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.
Responsibilities:
Communication and Collaboration:
Technology:
Efficiency, Process Improvement, and Business Growth:
EOE including Disabled and Veterans.
Required:
Preferred:
Northwestern Medicine is an equal opportunity employer (disability, VETS) and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status.
Background Check
Northwestern Medicine conducts a background check that includes criminal history on newly hired team members and, at times, internal transfers. If you are offered a position with us, you will be required to complete an authorization and disclosure form that gives Northwestern Medicine permission to run the background check. Results are evaluated on a case-by-case basis, and we follow all local, state, and federal laws, including the Illinois Health Care Worker Background Check Act.
Artificial Intelligence Disclosure
Artificial Intelligence (AI) tools may be used in some portions of the candidate review process for this position, however, all employment decisions will be made by a person.
Benefits
We offer a wide range of benefits that provide employees with tools and resources to improve their physical, emotional, and financial well-being while providing protection for unexpected life events.
Click on or copy and paste URL to your browser to view detailed benefits information
NorthwesternMedicine Career Page
https://jobs.nm.org/benefits
Please refer to the Benefits Eligibility by Employment Classification to determine benefits eligibility for job postings.
If sign-on bonus is included in a job posting eligibility is as followed: Internal employees and rehires who left Northwestern Medicine within 1 year are not eligible for the sign-on bonus. Exception: New graduate internal employees seeking their first licensed clinical position as a Registered Nurse at NM may be eligible.
Coordinates patient scheduling, registration, insurance checks, financial estimates, and customer service while maintaining accurate and confidential records.
At Northwestern Medicine, every patient interaction makes a difference in cultivating a positive workplace. This patient-first approach is what sets us apart as a leader in the healthcare industry. As an integral part of our team, you’ll have the opportunity to join our quest for better health care, no matter where you work within the Northwestern Medicine system. We pride ourselves on providing competitive benefits: from tuition reimbursement and loan forgiveness to 401(k) matching and lifecycle benefits, our goal is to take care of our employees. Ready to join our quest for better?
The Patient Access Specialist reflects the mission, vision, and values of NMHC, adheres to the organizations Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.
Responsibilities:
Communication and Collaboration:
Technology:
Efficiency, Process Improvement, and Business Growth:
EOE including Disabled and Veterans.
Required:
Preferred:
Northwestern Medicine is an equal opportunity employer (disability, VETS) and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status.
Background Check
Northwestern Medicine conducts a background check that includes criminal history on newly hired team members and, at times, internal transfers. If you are offered a position with us, you will be required to complete an authorization and disclosure form that gives Northwestern Medicine permission to run the background check. Results are evaluated on a case-by-case basis, and we follow all local, state, and federal laws, including the Illinois Health Care Worker Background Check Act.
Artificial Intelligence Disclosure
Artificial Intelligence (AI) tools may be used in some portions of the candidate review process for this position, however, all employment decisions will be made by a person.
Benefits
We offer a wide range of benefits that provide employees with tools and resources to improve their physical, emotional, and financial well-being while providing protection for unexpected life events.
Click on or copy and paste URL to your browser to view detailed benefits information
NorthwesternMedicine Career Page
https://jobs.nm.org/benefits
Please refer to the Benefits Eligibility by Employment Classification to determine benefits eligibility for job postings.
If sign-on bonus is included in a job posting eligibility is as followed: Internal employees and rehires who left Northwestern Medicine within 1 year are not eligible for the sign-on bonus. Exception: New graduate internal employees seeking their first licensed clinical position as a Registered Nurse at NM may be eligible.
Handles patient scheduling, registration, eligibility checks, financial estimates, and customer service while maintaining accurate and confidential healthcare records.
At Northwestern Medicine, every patient interaction makes a difference in cultivating a positive workplace. This patient-first approach is what sets us apart as a leader in the healthcare industry. As an integral part of our team, you’ll have the opportunity to join our quest for better health care, no matter where you work within the Northwestern Medicine system. We pride ourselves on providing competitive benefits: from tuition reimbursement and loan forgiveness to 401(k) matching and lifecycle benefits, our goal is to take care of our employees. Ready to join our quest for better?
The Patient Access Specialist reflects the mission, vision, and values of NMHC, adheres to the organizations Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.
Responsibilities:
Communication and Collaboration:
Technology:
Efficiency, Process Improvement, and Business Growth:
EOE including Disabled and Veterans.
Required:
Preferred:
Northwestern Medicine is an equal opportunity employer (disability, VETS) and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status.
Background Check
Northwestern Medicine conducts a background check that includes criminal history on newly hired team members and, at times, internal transfers. If you are offered a position with us, you will be required to complete an authorization and disclosure form that gives Northwestern Medicine permission to run the background check. Results are evaluated on a case-by-case basis, and we follow all local, state, and federal laws, including the Illinois Health Care Worker Background Check Act.
Artificial Intelligence Disclosure
Artificial Intelligence (AI) tools may be used in some portions of the candidate review process for this position, however, all employment decisions will be made by a person.
Benefits
We offer a wide range of benefits that provide employees with tools and resources to improve their physical, emotional, and financial well-being while providing protection for unexpected life events.
Click on or copy and paste URL to your browser to view detailed benefits information
NorthwesternMedicine Career Page
https://jobs.nm.org/benefits
Please refer to the Benefits Eligibility by Employment Classification to determine benefits eligibility for job postings.
If sign-on bonus is included in a job posting eligibility is as followed: Internal employees and rehires who left Northwestern Medicine within 1 year are not eligible for the sign-on bonus. Exception: New graduate internal employees seeking their first licensed clinical position as a Registered Nurse at NM may be eligible.
Leads Medical Affairs strategy, evidence generation, scientific engagement, and launch readiness across Recursion’s clinical portfolio.
At Recursion, we are decoding biology to radically improve lives. As Vice President, Medical Affairs, you will help shape how Recursion translates breakthrough science, clinical data, real-world evidence, and AI-enabled insights into meaningful impact for patients, clinicians, investigators, and health systems.
You will build and lead the Medical Affairs strategy across Recursion’s advancing clinical portfolio, with an initial focus on programs in areas of significant unmet need, including oncology, rare disease, immunology, and other priority therapeutic areas. This is a high-impact, cross-functional leadership role for a strategic medical affairs leader who can operate from early development through launch readiness, bring the external medical voice into portfolio decisions, and establish scalable capabilities for scientific engagement, evidence generation, medical communications, and medical excellence.
You will join Recursion’s Clinical Development organization, reporting to the Chief Medical Officer. The Clinical Development team is an empowered, execution-minded group responsible for translating Recursion’s innovative science into medicines for patients.
You will work closely with leaders across Development, Regulatory, Development Sciences, Clinical Operations, Data Science, Biology, Chemistry, Portfolio Strategy, Communications, Legal/Compliance, and future commercialization functions. Together, you will help ensure Recursion’s clinical programs are informed by robust evidence, external medical insight, patient need, and the full potential of the RecursionOS.
Working Location & Compensation:
This is a fully remote opportunity with occasional travel requirements. Travel may be necessary from time to time to support collaboration, team events, customer meetings, or other business needs.
At Recursion, we believe that every employee should be compensated fairly. Based on the skills, experience, and qualifications needed for this role, the estimated annual base salary range is:
In addition to base salary, this role is eligible for an annual bonus, equity compensation, and a comprehensive benefits package.
#LI-DB1
#LI-REMOTE
The Values We Hope You Share:
Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion
Recursion (NASDAQ: RXRX) is a clinical-stage TechBio company decoding biology to radically improve lives. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need. Enabling its mission is the Recursion OS, an AI-native, end-to-end drug discovery and development platform integrating biology, chemistry, and clinical development into a unified intelligence system. Powered by proprietary multimodal data, purpose-built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter — faster, better, and at scale — for patients who are waiting.
Recursion’s platform infrastructure is anchored in Salt Lake City, Utah and Milton Park, Oxfordshire, where its automated biology and chemistry laboratories generate proprietary data at industrial scale. Recursion also maintains offices in New York, Montréal, and London, three global hubs for talent and leadership at the intersection of AI and scientific innovation. Learn more at www.recursion.com, or connect on X and LinkedIn.
Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Accommodations are available on request for candidates taking part in all aspects of the selection process.
Leads clinical drug asset strategy, competitive positioning, cross-functional prioritization, and portfolio advancement for oncology and immunology programs.
The Impact You’ll Make
As the Recursion clinical asset pipeline continues to mature through key inflection points, the advancing assets require leaders who can translate scientific complexity into strategic clarity. In the role of Executive Director, Asset Team Lead, you will drive the strategic positioning of assets, ensuring that decisioning is grounded in competitive reality, differentiated by Recursion OS insights, and built to move with urgency for patient benefit. You will play a pivotal role ensuring advanced computational approaches and proprietary Recursion OS/ClinTech advantages are leveraged across the portfolio continuum, redefining traditional paradigms of drug development. Working across functional lines, you will partner with preclinical, clinical and platform teams, promoting communication, alignment and optimization of functional processes to ensure delivery of portfolio goals & transformative medicines for patients.
In this role, you will:
The Team You’ll Join
As an Executive Director, Asset Team Lead, you will work across the asset portfolio, operating as a senior strategic partner to leaders in Clinical Development, Discovery, ClinTech, Platform and BD. The Portfolio Team is execution-minded and analytically rigorous — fluent in both science and AI — and responsible for industrializing Recursion’s innovative science to advance medicines that matter. We break traditional silos, leveraging AI-powered platforms across data analysis, predictive modeling, RWE integration and patient stratification, all with the goal of optimizing asset positioning for the greatest benefit to patients.
The Experience You’ll Need
Working Location & Compensation:
This is a remote position based in the United States with required periodic travel. In addition to base salary, this role is eligible for an annual bonus, equity compensation, and a comprehensive benefits package.
#LI-EP1
#LI-REMOTE
The Values We Hope You Share:
Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion
Recursion (NASDAQ: RXRX) is a clinical-stage TechBio company decoding biology to radically improve lives. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need. Enabling its mission is the Recursion OS, an AI-native, end-to-end drug discovery and development platform integrating biology, chemistry, and clinical development into a unified intelligence system. Powered by proprietary multimodal data, purpose-built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter — faster, better, and at scale — for patients who are waiting.
Recursion’s platform infrastructure is anchored in Salt Lake City, Utah and Milton Park, Oxfordshire, where its automated biology and chemistry laboratories generate proprietary data at industrial scale. Recursion also maintains offices in New York, Montréal, and London, three global hubs for talent and leadership at the intersection of AI and scientific innovation. Learn more at www.recursion.com, or connect on X and LinkedIn.
Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Accommodations are available on request for candidates taking part in all aspects of the selection process.
Reviews medical content for MyHealthTeam to support accurate, patient-focused health information.
提供一對一遠程心理健康諮詢與臨床支持,協助客戶處理心理健康問題並與臨床團隊合作改進服務。
Manages and monitors clinical trial sites, ensuring protocol, regulatory, and ICH-GCP compliance while identifying risks and mentoring clinical operations staff.
About Karius
Karius is a life science, venture-backed clinical metagenomics company, focused on elevating patient care through microbial insights. We are committed to advancing diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. Through the use of genomics and AI, we are driven to improve the diagnostic landscape for infectious diseases. Karius delivers unprecedented diagnostic insight detecting microbial cell-free DNA circulating in the body to assist physicians to make rapid treatment decisions.
Position Summary
The Sr. Clinical Research Associate is responsible for advanced clinical site management and monitoring across Karius clinical programs, ensuring adherence to study protocols, ICH-GCP guidelines, sponsor procedures, and applicable regulatory requirements. Building on the full independent site ownership expected of a CRA II, the Sr. CRA manages more complex or higher-risk sites, applies advanced judgment to monitoring findings and emerging risks, and recommends corrective actions to support effective study execution. The Sr. CRA partners closely with Clinical Trial Managers and cross-functional teams and serves as a resource and mentor to less experienced Clinical Operations team members.
Why Should You Join Us?
Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The products Karius offers today are some of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our tests are the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.
Reports to: Sr. Manager, Clinical Site Operations
Location: Remote
Primary Responsibilities
Independently plan, conduct, and document on-site and remote monitoring visits, including site qualification visits (SQVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and closeout visits (COVs), in accordance with the Clinical Monitoring Plan, study protocols, ICH-GCP guidelines, sponsor procedures, and applicable regulatory requirements.
Apply a risk-based monitoring approach to evaluate site performance, protocol compliance, data quality, subject safety, and documentation completeness, and determine appropriate follow-up actions.
Conduct comprehensive source data verification (SDV) and source data review (SDR) to ensure Case Report Form (CRF) data is accurate, complete, and consistent with source documentation and the study protocol.
Independently manage day-to-day site relationships, driving enrollment momentum, query resolution, protocol compliance, timely completion of study activities, and overall site performance.
Proactively identify, assess, and document monitoring findings, site-level risks, protocol deviations, compliance concerns, and data trends, and escalate significant or recurring issues with recommended corrective actions.
Prepare and submit timely, high-quality monitoring visit reports and follow-up correspondence that clearly document site health, compliance status, findings, risks, required actions, and follow-up expectations.
Track monitoring findings and action items through resolution and verify completion and effectiveness during subsequent monitoring contacts.
Oversee the collection, review, and maintenance of essential regulatory and study documents to support ongoing inspection readiness.
Support and lead site-level study start-up activities, including site qualification, readiness assessments, SIVs, regulatory document collection, and site activation requirements.
Support and lead site-level closeout activities, including COVs, resolution of outstanding queries and monitoring findings, reconciliation activities, and completion of required site documentation.
Collaborate closely with Clinical Trial Managers and cross-functional partners to provide site-level monitoring insights, risk assessments, and recommendations that inform study planning and operational decision-making.
Mentor junior CRAs and CTAs on monitoring standards, visit preparation and execution, documentation practices, site management, and issue resolution.
Monitor subject safety throughout the study, including timely review and assessment of adverse events (AEs) and serious adverse events (SAEs), and promptly escalate safety signals or reporting concerns in accordance with sponsor and regulatory requirements.
Develop, track, and confirm implementation of corrective and preventive action plans (CAPAs) with investigative sites following protocol deviations, compliance concerns, or recurring performance issues, and verify effectiveness during subsequent monitoring visits.
Evaluate and maintain Investigator Site Files (ISFs) and Trial Master File (TMF) documentation in accordance with sponsor SOPs, the TMF Reference Model, and study requirements, proactively identifying and resolving documentation gaps.
Facilitate and support site staff training and retraining on protocol requirements, eClinical systems, specimen collection and handling, and study-specific procedures throughout study conduct.
What’s Fun About the Job? Karius is operating at the edge of what is now known to be possible in diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don’t suffice. You will get to see how much your work really matters.
Travel: Travel required up to 80%.
Physical Requirements
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, lab or clinical environment.
Position Requirements
Bachelor’s degree in a life sciences or health-related field, or equivalent combination of education and experience.
5-8 years of clinical monitoring experience, including independent on-site and remote monitoring across multi-site studies.
Experience monitoring studies for diagnostics, in vitro diagnostics (IVD), or regulated medical device products; familiarity with FDA device regulatory pathways strongly preferred.
Strong working knowledge of ICH-GCP E6(R2) guidelines, FDA regulations, including 21 CFR Parts 11, 50, 54, 56, 312, and 812, and applicable local requirements governing clinical research.
Familiarity with risk-based monitoring (RBM) frameworks and central monitoring methodologies.
Demonstrated ability to independently manage a portfolio of investigative sites, including enrollment tracking, query management, protocol deviation documentation, monitoring follow-up, and appropriate escalation of site-level risks.
Proficiency with electronic data capture (EDC) systems, such as iMediNet, Medidata Rave, Oracle InForm, or Veeva Vault EDC; clinical trial management systems (CTMS); and eTMF platforms, such as Veeva Vault TMF or Complion.
Proficiency with Microsoft Office Suite and Google Workspace, including Docs, Sheets, Slides, Gmail, and Drive.
Demonstrated experience preparing clear, accurate, and high-quality monitoring visit reports with actionable findings and follow-up requirements.
Strong written and verbal communication skills, including the ability to prepare concise monitoring reports, professional site correspondence, and clear study updates.
Demonstrated ability to build and sustain effective working relationships with investigative sites, Clinical Trial Managers, and cross-functional stakeholders.
Excellent organizational and time management skills, with the ability to manage a high-volume site portfolio, prioritize competing demands, and meet study timelines.
Ability to exercise sound judgment, independently resolve complex site-level issues, and escalate significant concerns with recommended corrective actions.
Ability to travel up to 80% of the time, including travel on short notice, and independently manage travel logistics.
ACRP Certified Clinical Research Associate (CCRA) or SoCRA Certified Clinical Research Professional (CCRP) certification preferred.
Experience monitoring infectious disease, microbiology, molecular diagnostics, or related clinical studies preferred.
Experience mentoring or training junior CRAs on monitoring practices, documentation standards, and site management techniques preferred.
Familiarity with laboratory-developed test (LDT) and CLIA regulatory frameworks preferred.
Personal Qualifications
Excellent communication and interpersonal skills with the ability to build trusted relationships with investigative sites and internal stakeholders.
Strong attention to detail, organization, and accountability.
Advanced problem-solving skills with the ability to assess issues and recommend practical solutions.
Ability to exercise sound judgment and work independently in complex or ambiguous situations.
Proactive approach to identifying risks, resolving issues, and escalating with recommendations.
Collaborative team player who mentors others and contributes to consistent, high-quality study execution.
Disclaimer
The above job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. Responsibilities and duties may change or be adjusted to meet the needs of the company, and additional duties may be assigned as necessary. The job description is subject to change at any time at the discretion of Karius.
At Karius, we value a diverse and inclusive workplace and provide equal employment opportunities for all applicants and employees and are committed to honor and invest in the full diversity of people, in our hiring, recruiting and development of employees across the Company. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at [email protected] and we will accommodate qualified individuals with disabilities.
$91,790 - $137,684 a year
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Manages and monitors clinical research sites, ensuring protocol, regulatory, and ICH-GCP compliance across infectious disease studies.
About Karius
Karius is a life science, venture-backed clinical metagenomics company, focused on elevating patient care through microbial insights. We are committed to advancing diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. Through the use of genomics and AI, we are driven to improve the diagnostic landscape for infectious diseases. Karius delivers unprecedented diagnostic insight detecting microbial cell-free DNA circulating in the body to assist physicians to make rapid treatment decisions.
Position Summary
The Sr. Clinical Research Associate is responsible for advanced clinical site management and monitoring across Karius clinical programs, ensuring adherence to study protocols, ICH-GCP guidelines, sponsor procedures, and applicable regulatory requirements. Building on the full independent site ownership expected of a CRA II, the Sr. CRA manages more complex or higher-risk sites, applies advanced judgment to monitoring findings and emerging risks, and recommends corrective actions to support effective study execution. The Sr. CRA partners closely with Clinical Trial Managers and cross-functional teams and serves as a resource and mentor to less experienced Clinical Operations team members.
Why Should You Join Us?
Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The products Karius offers today are some of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our tests are the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.
Reports to: Sr. Manager, Clinical Site Operations
Location: Remote
Primary Responsibilities
Independently plan, conduct, and document on-site and remote monitoring visits, including site qualification visits (SQVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and closeout visits (COVs), in accordance with the Clinical Monitoring Plan, study protocols, ICH-GCP guidelines, sponsor procedures, and applicable regulatory requirements.
Apply a risk-based monitoring approach to evaluate site performance, protocol compliance, data quality, subject safety, and documentation completeness, and determine appropriate follow-up actions.
Conduct comprehensive source data verification (SDV) and source data review (SDR) to ensure Case Report Form (CRF) data is accurate, complete, and consistent with source documentation and the study protocol.
Independently manage day-to-day site relationships, driving enrollment momentum, query resolution, protocol compliance, timely completion of study activities, and overall site performance.
Proactively identify, assess, and document monitoring findings, site-level risks, protocol deviations, compliance concerns, and data trends, and escalate significant or recurring issues with recommended corrective actions.
Prepare and submit timely, high-quality monitoring visit reports and follow-up correspondence that clearly document site health, compliance status, findings, risks, required actions, and follow-up expectations.
Track monitoring findings and action items through resolution and verify completion and effectiveness during subsequent monitoring contacts.
Oversee the collection, review, and maintenance of essential regulatory and study documents to support ongoing inspection readiness.
Support and lead site-level study start-up activities, including site qualification, readiness assessments, SIVs, regulatory document collection, and site activation requirements.
Support and lead site-level closeout activities, including COVs, resolution of outstanding queries and monitoring findings, reconciliation activities, and completion of required site documentation.
Collaborate closely with Clinical Trial Managers and cross-functional partners to provide site-level monitoring insights, risk assessments, and recommendations that inform study planning and operational decision-making.
Mentor junior CRAs and CTAs on monitoring standards, visit preparation and execution, documentation practices, site management, and issue resolution.
Monitor subject safety throughout the study, including timely review and assessment of adverse events (AEs) and serious adverse events (SAEs), and promptly escalate safety signals or reporting concerns in accordance with sponsor and regulatory requirements.
Develop, track, and confirm implementation of corrective and preventive action plans (CAPAs) with investigative sites following protocol deviations, compliance concerns, or recurring performance issues, and verify effectiveness during subsequent monitoring visits.
Evaluate and maintain Investigator Site Files (ISFs) and Trial Master File (TMF) documentation in accordance with sponsor SOPs, the TMF Reference Model, and study requirements, proactively identifying and resolving documentation gaps.
Facilitate and support site staff training and retraining on protocol requirements, eClinical systems, specimen collection and handling, and study-specific procedures throughout study conduct.
What’s Fun About the Job? Karius is operating at the edge of what is now known to be possible in diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don’t suffice. You will get to see how much your work really matters.
Travel: Travel required up to 80%.
Physical Requirements
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, lab or clinical environment.
Position Requirements
Bachelor’s degree in a life sciences or health-related field, or equivalent combination of education and experience.
5-8 years of clinical monitoring experience, including independent on-site and remote monitoring across multi-site studies.
Experience monitoring studies for diagnostics, in vitro diagnostics (IVD), or regulated medical device products; familiarity with FDA device regulatory pathways strongly preferred.
Strong working knowledge of ICH-GCP E6(R2) guidelines, FDA regulations, including 21 CFR Parts 11, 50, 54, 56, 312, and 812, and applicable local requirements governing clinical research.
Familiarity with risk-based monitoring (RBM) frameworks and central monitoring methodologies.
Demonstrated ability to independently manage a portfolio of investigative sites, including enrollment tracking, query management, protocol deviation documentation, monitoring follow-up, and appropriate escalation of site-level risks.
Proficiency with electronic data capture (EDC) systems, such as iMediNet, Medidata Rave, Oracle InForm, or Veeva Vault EDC; clinical trial management systems (CTMS); and eTMF platforms, such as Veeva Vault TMF or Complion.
Proficiency with Microsoft Office Suite and Google Workspace, including Docs, Sheets, Slides, Gmail, and Drive.
Demonstrated experience preparing clear, accurate, and high-quality monitoring visit reports with actionable findings and follow-up requirements.
Strong written and verbal communication skills, including the ability to prepare concise monitoring reports, professional site correspondence, and clear study updates.
Demonstrated ability to build and sustain effective working relationships with investigative sites, Clinical Trial Managers, and cross-functional stakeholders.
Excellent organizational and time management skills, with the ability to manage a high-volume site portfolio, prioritize competing demands, and meet study timelines.
Ability to exercise sound judgment, independently resolve complex site-level issues, and escalate significant concerns with recommended corrective actions.
Ability to travel up to 80% of the time, including travel on short notice, and independently manage travel logistics.
ACRP Certified Clinical Research Associate (CCRA) or SoCRA Certified Clinical Research Professional (CCRP) certification preferred.
Experience monitoring infectious disease, microbiology, molecular diagnostics, or related clinical studies preferred.
Experience mentoring or training junior CRAs on monitoring practices, documentation standards, and site management techniques preferred.
Familiarity with laboratory-developed test (LDT) and CLIA regulatory frameworks preferred.
Personal Qualifications
Excellent communication and interpersonal skills with the ability to build trusted relationships with investigative sites and internal stakeholders.
Strong attention to detail, organization, and accountability.
Advanced problem-solving skills with the ability to assess issues and recommend practical solutions.
Ability to exercise sound judgment and work independently in complex or ambiguous situations.
Proactive approach to identifying risks, resolving issues, and escalating with recommendations.
Collaborative team player who mentors others and contributes to consistent, high-quality study execution.
Disclaimer
The above job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. Responsibilities and duties may change or be adjusted to meet the needs of the company, and additional duties may be assigned as necessary. The job description is subject to change at any time at the discretion of Karius.
At Karius, we value a diverse and inclusive workplace and provide equal employment opportunities for all applicants and employees and are committed to honor and invest in the full diversity of people, in our hiring, recruiting and development of employees across the Company. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at [email protected] and we will accommodate qualified individuals with disabilities.
$91,790 - $137,684 a year
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Provides part-time psychiatric care and mental health support to Headspace members under a contract arrangement.
Provides direct virtual mental health therapy to clients as an independently licensed 1099 contractor.
Coordinates customer care and provides guidance through the Unite Us platform to connect people with needed services.
Leads medical strategy and clinical oversight for musculoskeletal surgery programs, partnering with health plans and providers to improve patient outcomes.
Provides telehealth mental health and personal growth support tailored to clients’ individual needs and goals.
Supports clinical projects and coordinates healthcare-related activities, documentation, and stakeholders.
Psychiatrist provides remote mental health consultations and psychiatric evaluations to patients via telemedicine platform.
Clinical executive leading regional health insurance operations, optimizing medical costs and care access while partnering with providers and internal teams.
Hi, we’re Oscar. We’re hiring a Market Medical Officer, Atlantic to join our Clinical Affairs team.
Oscar is the first health insurance company built around a full stack technology platform and a relentless focus on serving our members. We started Oscar in 2012 to create the kind of health insurance company we would want for ourselves—one that behaves like a doctor in the family.
About the role:
The Market Medical Officer is the clinical executive for the Atlantic region, partnering with P&L leadership to lead market performance, expand care access, and enhance affordability. You will optimize medical cost trends and reimbursement strategies to balance financial sustainability with plan performance. As the primary clinical liaison, the Market Medical Officer executes regional programs while seamlessly bridging corporate operations with local provider leadership.
You will report into our Vice President, Clinical Affairs.
Work Location: This position is fully remote and open to candidates residing in the U.S., excluding Alaska; Delaware; Hawaii; Louisiana; Montana; North Dakota; Oklahoma; West Virginia; Wyoming; and U.S. Territories. Daily work is completed from your home office, with occasional travel required for team meetings and company events. #LI-Remote
Pay Transparency: The base pay for this role in the states of California, Connecticut, New Jersey, New York, and Washington is: $290,628- $381,449 per year. The base pay for this role in all other locations is: $261,565 - $343,304 per year. You are also eligible for employee benefits, participation in Oscar’s unlimited vacation program, company equity grants and annual performance bonuses.
Responsibilities:
Requirements:
Education:
License and Certification:
Bonus points:
This is an authentic Oscar Health job opportunity.
At Oscar, being an Equal Opportunity Employer means more than upholding discrimination-free hiring practices. It means that we cultivate an environment where people can be their most authentic selves and find both belonging and support. We’re on a mission to change health care – an experience made whole by our unique backgrounds and perspectives.
Pay Transparency: Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience. Full-time employees are eligible for benefits including: medical, dental, and vision benefits, 11 paid holidays, paid sick time, paid parental leave, 401(k) plan participation, life and disability insurance, and paid wellness time and reimbursements.
Artificial Intelligence (AI): Our AI Guidelines outline the acceptable use of artificial intelligence for candidates and detail how we use AI to support our recruiting efforts.
Reasonable Accommodation: Oscar applicants are considered solely based on their qualifications, without regard to applicant’s disability or need for accommodation. Any Oscar applicant who requires reasonable accommodations during the application process should contact the Oscar Benefits Team (accommodations@hioscar.com) to make the need for an accommodation known.
California Residents: For information about our collection, use, and disclosure of applicants’ personal information as well as applicants’ rights over their personal information, please see our Privacy Policy.
Clinical executive who drives market performance, manages medical cost trends, and partners with providers to optimize regional health plan performance.
Hi, we’re Oscar. We’re hiring a Market Medical Director, Central to join our Clinical Affairs team.
Oscar is the first health insurance company built around a full stack technology platform and a relentless focus on serving our members. We started Oscar in 2012 to create the kind of health insurance company we would want for ourselves—one that behaves like a doctor in the family.
About the role:
The Market Medical Officer is the clinical executive for Central region, partnering with P&L leadership to drive market performance, expand care access, and enhance affordability. You will optimize medical cost trends and reimbursement strategies to balance financial sustainability with plan performance. As the primary clinical liaison, the Market Medical Officer executes regional initiatives while seamlessly bridging corporate operations with local provider leadership.
You will report into our VP of Clinical Affairs.
Work Location: This position is fully remote and open to candidates residing in the U.S., excluding Alaska; Delaware; Hawaii; Louisiana; Montana; North Dakota; Oklahoma; West Virginia; Wyoming; and U.S. Territories. Daily work is completed from your home office, with occasional travel required for team meetings and company events. #LI-Remote
Pay Transparency: The base pay for this role in the states of California, Connecticut, New Jersey, New York, and Washington is: $290,628- $381,449 per year. The base pay for this role in all other locations is: $261,565 - $343,304 per year. You are also eligible for employee benefits, participation in Oscar’s unlimited vacation program, company equity grants and annual performance bonuses.
Responsibilities:
Requirements:
Education:
License and Certification:
Bonus points:
This is an authentic Oscar Health job opportunity.
At Oscar, being an Equal Opportunity Employer means more than upholding discrimination-free hiring practices. It means that we cultivate an environment where people can be their most authentic selves and find both belonging and support. We’re on a mission to change health care – an experience made whole by our unique backgrounds and perspectives.
Pay Transparency: Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience. Full-time employees are eligible for benefits including: medical, dental, and vision benefits, 11 paid holidays, paid sick time, paid parental leave, 401(k) plan participation, life and disability insurance, and paid wellness time and reimbursements.
Artificial Intelligence (AI): Our AI Guidelines outline the acceptable use of artificial intelligence for candidates and detail how we use AI to support our recruiting efforts.
Reasonable Accommodation: Oscar applicants are considered solely based on their qualifications, without regard to applicant’s disability or need for accommodation. Any Oscar applicant who requires reasonable accommodations during the application process should contact the Oscar Benefits Team (accommodations@hioscar.com) to make the need for an accommodation known.
California Residents: For information about our collection, use, and disclosure of applicants’ personal information as well as applicants’ rights over their personal information, please see our Privacy Policy.
Provides psychotherapy and mental health counseling to individuals, groups, and families during evening hours.
Supervises clinical social workers and oversees mental health service delivery as a licensed clinical social work supervisor.