Benefits:- Health insurance
- Opportunity for advancement
- Paid time off
- Training & development
Clinical Research Coordinator (Experienced) — Job Description
Summary
The
Experienced Clinical Research Coordinator (CRC) independently manages all aspects of assigned clinical trials, ensuring protocol compliance, high‑quality data, and exceptional participant care. This role requires strong clinical judgment, mastery of study operations, and the ability to anticipate site needs, resolve issues proactively, and serve as a primary liaison between investigators, sponsors/CROs, and participants.
Key Responsibilities
- Study Management — Oversee day‑to‑day conduct of multiple clinical trials, ensuring adherence to protocol, GCP, ICH, and site SOPs.
- Participant Coordination — Screen, consent, and schedule participants; conduct study visits; collect vitals, labs, and assessments per protocol.
- Informed Consent Oversight — Lead the informed consent process, ensuring comprehension, documentation accuracy, and regulatory compliance.
- Source Documentation — Create and maintain complete, audit‑ready source documents; reconcile source with EDC entries.
- Data Management — Enter and clean data; resolve queries; ensure timely completion of all data deliverables.
- Regulatory & Compliance — Maintain essential documents, delegation logs, training records, and IRB submissions; ensure readiness for audits and monitoring visits.
- Specimen Handling — Process, label, ship, and track biological samples according to sponsor and lab requirements.
- Safety Reporting — Identify, document, and report AEs/SAEs; collaborate with investigators to assess causality and severity.
- Monitor & Sponsor Interaction — Lead monitoring visits; prepare documentation; address findings; maintain professional communication with sponsors/CROs.
- Study Startup & Closeout — Participate in feasibility, site qualification, SIVs, and closeout activities; ensure all tasks are completed on time.
- Operational Leadership — Mentor junior staff; identify workflow gaps; contribute to SOP updates and process improvements.
Required Qualifications
- Education — Bachelor’s degree in a health‑related field or equivalent clinical experience.
- Experience — 2–5+ years of hands‑on CRC experience managing trials independently.
- Technical Skills — Proficiency with EDC platforms (Rave, Inform, REDCap), CTMS systems, and Microsoft Office.
- Clinical Skills — Ability to perform vitals, ECGs, sample processing, and basic clinical procedures.
- Regulatory Knowledge — Strong understanding of GCP, ICH, FDA regulations, and IRB processes.
- Communication — Skilled in participant interaction, sponsor communication, and cross‑functional collaboration.
Preferred Qualifications
- Therapeutic Area Experience — Oncology, immunology, cardiology, CNS, or other specialized experience.
- Advanced Procedures — Experience with PK/PD sampling, complex visit schedules, or device trials.
- Leadership — Prior mentoring or training of junior CRCs or data staff.