Senior Clinical Research Associate - EAST COAST
Crinetics Pharmaceuticals
August 16, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Position Summary
- Participate in preparation and execution of Phase 1–3 clinical trials.
- Oversee clinical investigation progress through site qualification, initiation, interim, and close-out visits.
- Monitor trials per Good Clinical Practices (GCP)/ICH, SOPs, and study requirements; partner CRO oversight as needed.
Responsibilities (Essential Job Functions)
- Build/maintain investigational site relationships; support site selection/qualification and site activation tasks.
- Perform remote and on-site monitoring to protect subject rights/safety and ensure reliable study data.
- Conduct qualification/initiation/interim/close-out visits; produce accurate visit reports/letters timely.
- Review/verifiy study records (source documents, eCRFs, informed consent forms) for completeness/accuracy.
- Resolve data queries and/or entry errors; obtain additional info on potential serious adverse events.
- Assess/monitor investigational product receipt, storage, administration, accountability, and return.
- Collect/review regulatory documentation; submit essential documents to the TMF/eTMF and resolve quality issues.
- Train/assist site coordinators/investigators/CRO staff; communicate protocol conduct, recruitment, deviations, AE reporting, audits/inspections, and site performance.
- Identify and resolve site quality/compliance issues; escalate per pathway.
- Manage visit tracking in CTMS/eTMF; complete routine admin tasks and ensure trainings/deliverables are completed.
Required Qualifications/Skills
- BS in biological sciences (or related) + 5+ years as Clinical Research Associate (or equivalent).
- In-depth protocol/procedure knowledge; critical thinking, root-cause analysis, problem solving.
- Ability to motivate sites to meet timelines.
- Working knowledge of GCP/ICH/regulatory requirements; strong written and interpersonal communication; negotiation skills.
Preferred
- Startup/execution/close-out monitoring experience; risk-based monitoring experience preferred.
Benefits (as stated)
- Discretionary annual target bonus; stock options; ESPP; 401k match; medical/dental/vision/basic life; 20 days PTO; 10 paid holidays; winter shutdown.
- Participate in preparation and execution of Phase 1–3 clinical trials.
- Oversee clinical investigation progress through site qualification, initiation, interim, and close-out visits.
- Monitor trials per Good Clinical Practices (GCP)/ICH, SOPs, and study requirements; partner CRO oversight as needed.
Responsibilities (Essential Job Functions)
- Build/maintain investigational site relationships; support site selection/qualification and site activation tasks.
- Perform remote and on-site monitoring to protect subject rights/safety and ensure reliable study data.
- Conduct qualification/initiation/interim/close-out visits; produce accurate visit reports/letters timely.
- Review/verifiy study records (source documents, eCRFs, informed consent forms) for completeness/accuracy.
- Resolve data queries and/or entry errors; obtain additional info on potential serious adverse events.
- Assess/monitor investigational product receipt, storage, administration, accountability, and return.
- Collect/review regulatory documentation; submit essential documents to the TMF/eTMF and resolve quality issues.
- Train/assist site coordinators/investigators/CRO staff; communicate protocol conduct, recruitment, deviations, AE reporting, audits/inspections, and site performance.
- Identify and resolve site quality/compliance issues; escalate per pathway.
- Manage visit tracking in CTMS/eTMF; complete routine admin tasks and ensure trainings/deliverables are completed.
Required Qualifications/Skills
- BS in biological sciences (or related) + 5+ years as Clinical Research Associate (or equivalent).
- In-depth protocol/procedure knowledge; critical thinking, root-cause analysis, problem solving.
- Ability to motivate sites to meet timelines.
- Working knowledge of GCP/ICH/regulatory requirements; strong written and interpersonal communication; negotiation skills.
Preferred
- Startup/execution/close-out monitoring experience; risk-based monitoring experience preferred.
Benefits (as stated)
- Discretionary annual target bonus; stock options; ESPP; 401k match; medical/dental/vision/basic life; 20 days PTO; 10 paid holidays; winter shutdown.