Senior Clinical Research Associate, Field Monitor
ImmunityBio, Inc.
August 20, 2026
Remote
United States
Clinical Research and Development
Position Summary
Senior Clinical Research Associate to support clinical research teams and ensure high-quality study conduct (patient safety, data reliability, scientific integrity, regulatory compliance) via protocol interpretation, proactive risk mitigation (RBQM/ICH E6(R3)), and clinical trial support.
Essential Functions
- Execute site selection, initiation, routine monitoring, and close-out for assigned trials.
- Perform remote, risk-based, and on-site monitoring tasks, including SDV and investigational product (IP) accountability.
- Identify and mitigate risks; evaluate site metrics and address deviations early.
- Interpret medical/scientific intent of protocols, procedures, logistics, and subject risks.
- Act as Subject Matter Expert (SME) for sites: protocol interpretation, eligibility, and safety reporting guidance.
- Ensure data accuracy/completeness; review CRFs, resolve queries, and treat deviations as signals for retraining.
- Support eTMF essential document collection/maintenance.
- Drive recruitment/retention strategies using DEI best practices to meet enrollment targets.
- Develop/review training materials (e.g., initiation slides, procedures manuals, informed consent templates).
- Coordinate with Supply Chain on IP supply, temperature excursions, and specimen logistics.
- Support audits/inspections and CAPA development.
- Mentor/train newly hired CRAs; perform ad-hoc cross-functional projects.
Education & Experience
- Bachelor’s degree required (clinical research/science/health preferred); OR RN with 5+ years on-site monitoring.
- 6+ years clinical trial experience (pharma/biotech/CRO/healthcare) required.
- 4+ years independent on-site and remote monitoring required.
- Valid driver’s license required.
Knowledge/Skills
- Advanced drug development knowledge; ICH-GCP E6(R3); CFR.
- Proficiency with EDC, eTMF, CTMS, MS Office, and Adobe.
- Strong presentation, organization, detail/time management.
- Independent, collaborative, inclusive mindset; follow SOPs and confidentiality.
Working Environment
- Travel 50–75% (overnight as needed); remote with flexible hours.
Benefits (eligible employees)
Medical/dental/vision; EAP; life/AD&D; short- and long-term disability; FSA (health/dependent care); 401(k) match; paid time off and holidays; PTO terms by exempt/non-exempt.
Application Instructions
- Application window: anticipated to close in 60 days from posting (or sooner if filled/closed).
Senior Clinical Research Associate to support clinical research teams and ensure high-quality study conduct (patient safety, data reliability, scientific integrity, regulatory compliance) via protocol interpretation, proactive risk mitigation (RBQM/ICH E6(R3)), and clinical trial support.
Essential Functions
- Execute site selection, initiation, routine monitoring, and close-out for assigned trials.
- Perform remote, risk-based, and on-site monitoring tasks, including SDV and investigational product (IP) accountability.
- Identify and mitigate risks; evaluate site metrics and address deviations early.
- Interpret medical/scientific intent of protocols, procedures, logistics, and subject risks.
- Act as Subject Matter Expert (SME) for sites: protocol interpretation, eligibility, and safety reporting guidance.
- Ensure data accuracy/completeness; review CRFs, resolve queries, and treat deviations as signals for retraining.
- Support eTMF essential document collection/maintenance.
- Drive recruitment/retention strategies using DEI best practices to meet enrollment targets.
- Develop/review training materials (e.g., initiation slides, procedures manuals, informed consent templates).
- Coordinate with Supply Chain on IP supply, temperature excursions, and specimen logistics.
- Support audits/inspections and CAPA development.
- Mentor/train newly hired CRAs; perform ad-hoc cross-functional projects.
Education & Experience
- Bachelor’s degree required (clinical research/science/health preferred); OR RN with 5+ years on-site monitoring.
- 6+ years clinical trial experience (pharma/biotech/CRO/healthcare) required.
- 4+ years independent on-site and remote monitoring required.
- Valid driver’s license required.
Knowledge/Skills
- Advanced drug development knowledge; ICH-GCP E6(R3); CFR.
- Proficiency with EDC, eTMF, CTMS, MS Office, and Adobe.
- Strong presentation, organization, detail/time management.
- Independent, collaborative, inclusive mindset; follow SOPs and confidentiality.
Working Environment
- Travel 50–75% (overnight as needed); remote with flexible hours.
Benefits (eligible employees)
Medical/dental/vision; EAP; life/AD&D; short- and long-term disability; FSA (health/dependent care); 401(k) match; paid time off and holidays; PTO terms by exempt/non-exempt.
Application Instructions
- Application window: anticipated to close in 60 days from posting (or sooner if filled/closed).