Job Description

📋 Clinical Research Coordinator (CRC) - Job Description

Location: Evergreen Park

Employment Type: Full-Time/Contract: Six months contract to permanent hire

Job Summary

The Clinical Research Coordinator (CRC) plays a critical role in the planning, coordination, and conduct of clinical trials under the direct supervision of the Principal Investigator (PI). The CRC ensures that all clinical research activities are executed in accordance with the study protocol, Standard Operating Procedures (SOPs), institutional policies, and all applicable regulatory guidelines, including Good Clinical Practice (GCP) and ICH guidelines . The ideal candidate is highly organized, detail-oriented, and committed to maintaining the integrity and quality of clinical trial data.

Key Responsibilities

1. Regulatory Compliance and Study Documentation

• Maintain comprehensive regulatory files (Investigator Site File - ISF) for all assigned studies, ensuring all essential documents are current and inspection-ready.
• Manage communication and submissions with the Institutional Review Board (IRB) , including initial submissions, continuing reviews, amendments, and study closures, to ensure ethical and regulatory oversight.
• Prepare and conduct visits (Qualifying Visits - QV , Site Initiation Visits - SIV , Interim Monitoring Visits - IMVs , Close-Out Visits - COV ) with sponsor/CRO teams.

2. Patient Recruitment and Study Execution

• Recruit and screen potential patients for eligibility according to the study inclusion/exclusion criteria.
• Execute the Informed Consent process with eligible participants, ensuring all aspects are performed in strict adherence to ICH and GCP guidelines .
• Schedule and conduct study visits , performing all assessments and procedures (including vitals, ECG , and other required study assessments) exactly as outlined in the study protocol.
• Document all study visits meticulously in source documents following the ALCOA-CCC principles (Attributable, Legible, Contemporaneous, Original, Accurate; Complete, Consistent, Enduring).

3. Investigational Product and Specimen Management

• Monitor, dispense, and collect investigational product (IP) in accordance with protocol and sponsor requirements.
• Maintain strict IP accountability logs and temperature logs , reporting any temperature excursions immediately and working in Interactive Response Technology (IRT) systems for randomization and drug supply management.
• Perform phlebotomy (blood draw) and collect urine samples ; process, package, and ship all blood and urine specimens according to protocol specifications and IATA guidelines.

4. Data Management and Safety Reporting

• Enter source document data into the respective Electronic Data Capture (EDC) vendor system (e.g., Medidata RAVE) in a timely manner.
• Respond to data queries from the sponsor/CRO promptly and accurately.
• Record all adverse events (AEs) and serious adverse events (SAEs) per sponsor and regulatory guidance. Maintain timely follow-up with the participant to document the resolution of the adverse event.

Qualifications

Required:

• Bachelor’s degree in a health-related field (e.g., nursing, biology, public health) or equivalent relevant experience.
• Minimum of 1-3 years of experience working as a Clinical Research Coordinator or in a related research capacity.
• Strong working knowledge of GCP/ICH guidelines and FDA regulations.
• Proficiency in performing phlebotomy and basic laboratory specimen processing.

Preferred:

• Certification as a Certified Clinical Research Coordinator ( CCRC or equivalent).
• Experience with multiple EDC systems (e.g., Medidata RAVE).
• Familiarity with complex protocols and multiple therapeutic areas.

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