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Clinical Research Coordinator I

Clinical Research Coordinator I

Title: Clinical Research Coordinator I
Reports To: Clinical Trials Manager
Status: Full-Time/Non-Exempt
Regular/Temporary: Regular
Last Reviewed: June 2025
Site: VA Pittsburgh Healthcare System
Salary Range:  $24.50-$31.00 per hour

Summary

The Clinical Research Coordinator I (CRC) plans, initiates and implements assigned clinical trials in collaboration with a team of healthcare professionals, to ensure timely, high-quality care. The CRC coordinates care of research participants enrolled into Phase II-IV clinical trials across a variety of disciplines and investigators. Trials may be sponsored by federal agencies including VA, NIH or DOD and pharmaceutical sponsors or CRO’s.

Essential Duties

  • Utilizing Good Clinical Practice, the CRC ensures assigned studies are conducted in accordance with the (FDA) and the Office for Human Research Protections (OHRP)
  • Interfaces with research participants, Principal Investigator (PI) and clinical staff to support efforts to determine eligibility and to obtain informed consent according to protocol
  • Educates participants, their families and staff in protocol processes, therapies, and/or treatments being studied
  • Responsible for follow-up and active patient monitoring per study protocol.
  • Work with the PI, study sponsor and applicable VA service lines to develop recruitment strategies for their assigned studies.
  • Responsible for all data collection and query resolution within the EDC.
  • Collaborates with Investigational Drug Service(IDS) and clinical staff to ensure study drug administration; Maintains subject drug accountability and dispensation records.
  • Collect, process and ship applicable specimens (blood, cultures, tissue) for laboratory analysis as described in study protocol(s).
  • Inspect completed source documentation, and study files to ensure completeness.
  • Meet with internal and external monitors and/or auditors to ensure accuracy of subject data and compliance with assigned research protocols.
  • Comply with standard operating procedures of the sponsor, Institutional review board (IRB), VAMC, VA Research Office and CRO involved with the trial.
  • Compile and submit reports, documents, and correspondence as necessary to the IRB, sponsor, and CRO.
  • Report non-compliance events, adverse advents and serious adverse events in accordance with the Institutional Review Board (IRB) Standard Operating Procedures, sponsor guidelines, and federal regulations.
  • Provides cross coverage for trials as assigned.
  • Update the Clinical Trials Management System in a timely manner, which includes but is not limited to subject enrollment, patient payments and entering study milestones.
  • Schedule and attend all Site Initiation Visits, Monitoring Visits, Close-Out Visits etc. for all assigned studies.
  • Occasional travel to attend sponsor study training meetings (required)
  • Complete all research and study specific trainings as required by the VA and study sponsor(s).
  • Other duties as assigned.

Qualifications

  • High School Diploma / GED required
  • At least two (2) years of clinically relevant experience required.
  • Phlebotomy, collection of vitals and EKG skills preferred.
  • Strong interpersonal, customer service, and multi-tasking skills are critical
  • Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
  • Working knowledge in Microsoft Office Outlook, Teams Word and Excel
  • Experience navigating an electronic health system required
  • Must possess excellent organization and time management skills with the ability to work well independently as well as in team environment
  • Must have professional demeanor and strong communication skills with the public as well as physicians/researchers

Send resumes to samantha.gray6@va.gov