Clinical Research Coordinator

This is a full-time role for an experienced and energetic Clinical Research Coordinator at the VA Pittsburgh Medical Center located in Pittsburgh, PA. The CRC will be responsible for coordinating and managing clinical research studies sponsored by industry, foundation, and/or Federal funding sources. This position will primarily support a team of Oncology investigators but will also collaborate with multidisciplinary teams to ensure regulatory compliance throughout the research process.

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