Clinical Research Coordinator or Trainee
Working Title: Clinical Research Coordinator or Trainee
Position Type: University Managerial and Professional Staff
Department: Department of Psychiatric Medicine
Posting Date: 04-04-2018
The Department of Psychiatry and Neurobehavioral Sciences in the Center for Psychiatric and Clinical Research at the University of Virginia is seeking a Clinical Research Coordinator or CRC Trainee to assist in research involving phase I-IV investigational drug trials for a range of psychiatric disorders.
The incumbent assists the trial's Principal Investigator to identify, recruit, and enroll clinical trial candidates. The incumbent collects and analyzes clinical research data; assists with creating and monitoring clinical trial budgets and preparing appropriate documentation; and ensures compliance with protocol guidelines and requirements of regulatory agencies. This position participates in educational activities offered by the department, institution, and outside organizations to maintain and build awareness of issues surrounding clinical trials. The incumbent communicates with sponsors, IRB staff, and other UVa entities to ensure progress of trials, as needed. In addition this position assists with preparation of all IRB submissions for sponsored and investigator-initiated clinical trials, including new protocols; protocol modifications, continuations, and closures; advertisements; and safety reports.
This position requires a Bachelor's degree.
For the Trainee level no experience is required, but one year of relevant work experience in clinical trials and/or research protocols is preferred. A Bachelor's degree in Biology, Psychology, Public Health, or a related field is also preferred.
For the Clinical Research Coordinator, Non-licensed level, at least one year of previous clinical research coordination experience is required.
Required Knowledge, Skills and Abilities:
1. Ability to learn health care, medical documentation, and terminology.
2. Ability to effectively communicate accurate and comprehensive information to other personnel and professionals outside of the UVA Health System.
3. Ability to learn and understand current federal, state, and local regulations governing clinical trial activities including record retention requirements.
4. Ability to learn IRB regulatory submission policies and procedures.
5. Ability to maintain regulatory documentation for industry-sponsored and investigator-initiated trials.
6. Strong writing skills for assisting with drafting of investigator-initiated protocols and related documents.
7. Strong organizational and prioritization skills for maintaining tasks and documentations for multiple protocols simultaneously is a necessity.
8. Ability to perform computer-based work on a regular basis with outstanding level of completeness and validity that lead to the preservation of current databases of trial information.
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