Clinical Research Coordinator II

High school diploma or GED required; Bachelor’s degree preferred

At least one year of experience coordinating Phase 2–4 industry-sponsored clinical trials

Strong understanding of FDA regulations, ICH-GCP, and clinical trial operations

Experience with EDC, IVRS, and clinical research platforms

Proficiency in medical terminology and clinical documentation

Strong organizational skills with the ability to manage multiple studies

Coordinate all aspects of assigned clinical trials from site initiation through close-out

Conduct subject visits and ensure accurate, timely documentation in compliance with ALCOA-C standards

Maintain compliance with protocols, GCP/ICH guidelines, FDA regulations, IRB requirements, and SOPs

Manage subject recruitment, informed consent, and retention activities

Ensure timely EDC data entry and resolution of queries

Report and follow up on AEs, SAEs, and protocol deviations

Peninsula Research Associates (PRA) is dedicated to advancing medical treatments through the use of innovative techniques and increasing awareness. PRA has achieved significant study results in allergy, asthma, vaccines, otitis media and sinusitis treatment and has earned a reputation for conducting quality research.