Clinical Research Coordinator I

Schuylkill • Allentown, PA

3d • Onsite

About The Position

Plans, initiates, coordinates, and implements minimal-risk studies in collaboration with other staff. Coordinates regulatory management of assigned clinical trials; processes and ships phlebotomy laboratory samples according to trial requirements; and collects, records, and reports study data. The role also coordinates protocol-based patient assessments and maintains clinical research documentation in collaboration with the Principal Investigator and study team. The coordinator participates in sponsor and agency monitor visits to evaluate the accuracy and quality of collected data.

Requirements

• Bachelor’s degree or five years of research experience.
• Two years of experience in a clinical environment.
• Self-motivated and organized to ensure timely implementation of research protocols and successful outcomes.

Nice To Haves

• Knowledge of medical terminology.
• Knowledge of clinical research terminology.
• Knowledge and skill in the therapeutic area and research.
• CCRP (Certified Clinical Research Professional).
• SCRA (State of Pennsylvania), upon hire.
• MLT (Medical Laboratory Technician AMT, State of Pennsylvania), upon hire.

Responsibilities

• Plan, implement, and conduct approved research studies.
• Conduct and document the informed consent process for minimal-risk studies.
• Perform phlebotomy and process, store, and ship laboratory samples as required by clinical research trials.
• Coordinate regulatory management of assigned clinical trials, including assisting with NORI/IRB submissions and maintaining regulatory and legal documents.
• Coordinate and manage patient assessments according to protocol standards.
• Collect, record, and report data for assigned research studies.
• Maintain clinical research study documentation in collaboration with the Principal Investigator and study team.
• Participate in monitor visits with sponsors and related agencies to evaluate the accuracy and quality of collected data.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level