Job detail

Part-time Clinical Research Coordinator 3; Center for Psychiatric Clinical Research

UVA Health

#FDA #Epic #Clinical Research #CRO #CCRC #CCRP #IRB #Protocol Deviations #OnCore

Quick overview

The coordinator manages clinical trial conduct, including regulatory documentation, IRB submissions, and patient recruitment and enrollment. They are also responsible for specimen processing, study billing reconciliation, and communicating with sponsors and CROs.

Requirements summary

A Bachelor's degree and at least 3 years of clinical research experience are required, though a Master's degree can substitute for one year of experience. CCRC or CCRP certification is preferred at hire and required within one year.

bachelor degreepostgraduate degreeprofessional certificateRegulatory ComplianceSpecimen ProcessingEpicBudget DevelopmentPatient RecruitmentInformed ConsentPatient ScreeningClinical Research CoordinationFDA RegulationsClinical Trial ManagementIRB SubmissionOnCoreClinical BillingIRB ProCRConnectFlorence

Job description

The UVA Center for Psychiatric Clinical Research seeks a Clinical Research Coordinator 3.
The CRC will manage the basic elements of clinical trial conduct and demonstrate a solid understanding of clinical research compliance.
The CRC will be involved in most aspects of clinical research conduct and will continue to benefit from the opportunity to engage in additional on-the-job training and mentorship opportunities to continue to advance on the clinical research career path.
The CRC works under the moderate supervision of a Principal Investigator and/or an experienced CRC and will manage a reasonable portfolio of clinical trials or research projects as assigned by a supervisor.
Duties Include: Work closely with Principal Investigators and other study team members on all clinical research projects assigned.
Be familiar with study start-up processes and requirements for: non-disclosure agreements, data use and material transfer agreements, clinical trial agreements, development of clinical trial budgets (from template).
Demonstrate a working knowledge of the regulatory framework for FDA and non-FDA regulated studies.
Prepare and submit all regulatory documentation to the IRB such as: personnel changes, annual protocol continuations, protocol modifications, adverse event reports, unanticipated events.
Document and report protocol deviations.
Manage study recruitment and enrollment efforts including: screen and identify eligible patients, obtain and document informed consent and enrollment.
Collect, process, store and ship study specimens as needed.
Assist in preparation, maintenance or creation of study documents such as: study visit schedules, study drug diaries, monitoring or training logs, equipment records or study communications.
Confirm Sponsor is invoiced for study activity.
Reconcile study billing, identify charges covered by the study, other payment issues Notify PI and/or supervisor of any potential issues with the study or subject status.
Communicate effectively with study Sponsor(s) and CROs Proficient user of the various electronic platforms utilized in clinical research such as: IRB Pro, Florence, CRConnect, OnCore, e-regulatory platforms and Epic.
Training provided for active study vendors as they vary. (Ex: Clario, Suvoda, Zelta, iMetadata) Demonstrate a continuously increasing level of clinical research knowledge gained through active participation in training and mentorship opportunities as well as self-guided learning.

Part-time Clinical Research Coordinator 3; Center for Psychiatric Clinical Research

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