Clinical Research Coordinator I/II

Benefits

Qualifications

• •Multi-disciplinary collaboration with seasoned investigators and clinical staff
• •Exposure to complex, meaningful studies—not just high-volume turnover
• •A site with long-standing credibility and research maturity
• •Backing of a growing research network with resources and stability
• •At least one full year of experience coordinating multiple Phase 2–4 industry-sponsored clinical trials required
• •Experience with regulatory, patient visits, consenting, interacting directly with sponsors, and scheduling patient visits required
• •Heavily prefer those who are trained and experienced in phlebotomy
• •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
• •Clear, professional verbal and written communication skills
• •Comfortable working onsite in a collaborative, clinical environment
• •CRCs who want structure, support, and accountability
• •Professionals who value teamwork over silos
• •Coordinators who care about data quality, patient experience, and compliance
• •Those ready to grow within a stable, well-established research site
• •14 more items(s)

Responsibilities

• •If you’re an experienced Clinical Research Coordinator I, or II who values strong operations, multidisciplinary collaboration, and a schedule that actually supports work–life balance, Peninsula Research Associates may be the right next step in your career
• •Strong operational support and clear SOPs
• •This role is ideal for CRCs who enjoy owning their studies, working with competent teams, and being trusted to execute with precision
• •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
• •Collaborate with investigators, sponsors/CROs, labs, and internal teams
• •Prepare for and participate in monitoring visits, audits, and inspections
• •Maintain regulatory documentation and ensure training compliance for amendments and systems
• •Perform study procedures such as phlebotomy, ECGs, and sample processing (as trained)
• •Attend investigator meetings and provide cross-functional support as needed
• •Maintain working knowledge of protocols, lab manuals, equipment calibration, and inventory
• •12 more items(s)