Senior Clinical Research Coordinator - Onsite Trials

Revival Research Institute, LLC

Cary (NC)

On-site

USD 60,000 - 85,000

Full time

14 days+

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Job summary

Revival Research Institute, LLC is seeking an experienced Site-Based Clinical Research Coordinator to take ownership of assigned protocols from initiation to close-out. You will coordinate multiple concurrent studies, supervise study visits, ensure regulatory readiness, and maintain robust sponsor and IRB communication.

Responsibilities include screening, consent, data management in EDC, IP accountability, and adherence to ICH-GCP, FDA regs, and HIPAA.

Qualifications

2+ years as a Clinical Research Coordinator at a research site, primary coordinator on industry-sponsored interventional trials.
Demonstrated experience independently obtaining informed consent on interventional protocols.
Hands-on experience with EDC platforms.
Demonstrated experience hosting monitoring visits and resolving monitoring findings independently.
Working knowledge of ICH-GCP E6(R3) and 21 CFR Parts 11, 50, 54, 56, and 312, and HIPAA.
Current phlebotomy competency, as well as IV certification, is preferred.
Proficiency in conducting physical assessments, including vital signs and 12-lead ECG acquisition.
Master's degree in a health-related field, or equivalent clinical research site experience.
Strong computer proficiency including Microsoft Office (Word, Excel, Outlook); excellent verbal and written communication; ability to work independently, manage competing protocol deadlines, and assume ownership of assigned studies.
Ability to work on-site in Cary, NC.

Responsibilities

Screening, recruitment, and enrollment per protocol.
Independently obtain informed consent on interventional protocols.
Conduct study visits per protocol.
Data and monitoring: maintain source documents and enter data into EDC on sponsor timelines.
Host monitoring visits and resolve CRA findings and follow-up letters.
Regulatory and quality: organize trial documents; maintain regulatory binders; implement QC measures.
Sponsor and IRB communication: act as day-to-day contact and submit regulatory documents.
Investigational product accountability: manage IP receipt, dispensing, storage, and temperature documentation.
Maintain knowledge of ICH-GCP and FDA regs; pursue training.
Participant communication and confidentiality: interact with participants; support retention; HIPAA compliance.