Job Description
Position Summary:
VCU Department of Pediatrics are not just caring for kids and families: we're discovering new treatments, improving outcomes, and researching innovative new ideas. The Pediatric Research Office is committed to supporting VCU clinical researchers in advancing investigative medicine.
This entry level position will support the Division of Pediatric Endocrinology and others, as a member of the Pediatric Research Office.
The Clinical Research Coordinator (CRC) 1 supports upper level/senior CRCs and Principal Investigators (PI) in activities required for activation, execution, and management of clinical, patient-oriented research studies or protocols. Typical duties include but are not limited to determining participant eligibility; serve as patient/participant recruiter and educator; and perform a variety of complex activities involved in the collection, compilation, and documentation of clinical research data.
This role includes responsibilities of the CRC to work independently and as a member of a team. Working under general supervision, they resolve most standard issues independently and refer complex issues to the upper-level manager or the PI, as appropriate.
This role will report in-person in the VCU Health downtown area of Richmond, VA, with the potential for remote/hybrid work following onboarding, 3-6 months training, and manager approval.
Core Responsibilities: Study Conduct (60%):
-Maintain understanding of clinical research duties from study initiation to close-out and ensure protocol compliance.
-Assist in subject recruitment. Tasks may include: attend clinics/rounds to discuss studies with patients and care team members, screen patient charts, determine eligibility for multiple studies, develop recruitment plans and reports of expected vs observed enrollment rate, etc.
-Assist with consent and assent and act as a patient/family resource for further questions and/or concerns.
-Assist with coordination of patient study visits with upper level/senior CRC(s), study investigators and other clinicians; study visits may include biospecimen, data collection, and real-time instruction for medical team administering investigative medicine.
-Assist in the preparation of IRB submissions, including initial submissions, continuing reviews, amendments, safety reports, and serious adverse event reporting. Ensure all IRB submissions are complete and submitted on time.
-Maintain effective and ongoing communication with sponsor, participants, Pediatric Research Office, care team, and investigators during the study.
-Ensure patient safety is a top priority in the conduct of clinical studies.
-Follow VCU and SOM internal processes to ensure compliance with VCU policies related to research activities and ensure compliance with federal and state regulatory standards.
-Complete VCUHS orientation and training modules as required for the department and clinical research projects to obtain access to VCUHS clinical systems and clinical data. Conduct applicable clinical activities only as approved for each position on the clinical permission table and required for each clinical research project. Follow all VCUHS policies & procedures, including vaccination requirements and requirements for annual training. Job duties may include entering information into the medical record; provide documentation assistance with transcribing provider orders; performing study assessments, including point of care testing; providing documentation assistance with transcribing provider orders in EPIC; the handling, transportation, access to and/or contact with medications and related supplies; minimum qualifications include HIPAA training, EMR navigation/computerized order entry. Performance and continued competence will be periodically assessed.
-Other duties as assigned.
Data Management & Documentation (25%): -Enter subject data into case report forms, databases, and VCU/VCUHS systems in a timely and accurate manner, and in accordance with sponsor and institution requirements. Build databases and logs as needed.
-Assist in maintaining study files according to GCP guidelines and in audit ready condition. Retain all study records in accordance with sponsor requirements and/or university policies and procedures. Participate in auditing and monitoring activities as assigned.
-Other duties as assigned.
General / Administrative (15%): -Support the Pediatric Research Office and assigned divisions by attending events and trainings, assist team members in various study tasks (as needed, or as based on individual skill/education), and share information.
-Provide cross-coverage across studies within the Pediatric Research Office in true collaboration, which may include supporting other team members and performing administrative tasks as assigned.
Job Tags
Full time, Work at office,