Coordinate day-to-day clinical trial activities including participant recruitment, informed consent, specimen collection/handling, basic clinical procedures, regulatory document maintenance, data entry in EDC/REDCap, and communication with sponsors, monitors, and IRBs to ensure protocol compliance.
Job Summary:
We are seeking a highly organized and motivated Clinical Research Coordinator (CRC) to join our research team in San Jose, California. The CRC will coordinate and support all aspects of clinical trials and research studies, including subject recruitment, data collection, regulatory compliance, and specimen handling. Candidates with current Phlebotomy certification or Medical Assistant (MA) certification are strongly preferred, as this role may include specimen collection and basic clinical procedures.
Key Responsibilities:
- Coordinate day-to-day clinical research activities to ensure study protocols are followed.
- Recruit, screen, and enroll study participants.
- Obtain informed consent and ensure ethical conduct in all study interactions.
- Collect, process, and ship biological specimens per protocol (e.g., blood draws, urine samples).
- Perform basic clinical procedures as permitted by certification (e.g., vital signs, EKGs).
- Maintain accurate and timely documentation in case report forms and electronic databases.
- Communicate with sponsors, monitors, and IRBs regarding study progress and compliance.
- Schedule participant visits and follow-ups; ensure visit windows are met.
- Ensure proper storage, handling, and accountability of investigational products, if applicable.
- Maintain regulatory documents and assist with IRB submissions.
Qualifications:
- Bachelor's degree in a health-related field required.
- At least 1–2 years of experience in clinical research preferred.
- Phlebotomy certification or MA certification preferred.
- Knowledge of Good Clinical Practice (GCP) and regulatory guidelines.
- Excellent organizational skills and attention to detail.
- Strong interpersonal and communication skills.
- Proficiency in Microsoft Office and electronic data capture systems (e.g., REDCap, EDC platforms).
- Ability to work independently and as part of a multidisciplinary team.
Preferred Qualifications:
- Experience working in clinical trials, especially in a hospital or academic setting.
- Familiarity with IRB processes and clinical trial documentation.
- Bilingual skills (depending on patient population) may be a plus.
Job Type: Full-time
Pay: $22-25/hr
Work Location: In person
Schedule:
- 8 hour shift
- Monday to Friday
- Weekends as needed
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