Part-time Clinical Research Coordinator 3; Center for Psychiatric Clinical Research
About The Position
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.
Requirements
- Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
- Minimum of 3 years of clinical research experience required.
- Master’s degree may substitute for 1 year of clinical research experience.
- Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.
- Licensed to Practice in Clinical Profession such as (but not limited to): Registered Nurse, Athletic Training, Pharmacology, Medical Technology, Physical Therapy, Registered Respiratory Therapy
Nice To Haves
- Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.
Responsibilities
- 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.
- In addition to the above job responsibilities, other duties may be assigned.
Benefits
- Benefits eligibility will be based on scheduled hours in accordance with university policy.
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What This Job Offers
Job Type
Part-time
Career Level
Mid Level
