for the Lead Clinical Research Coordinator - Full time, Days, 8hr position
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Lead Clinical Research Coordinator - Full time, Days, 8hr
Orange - St. Joseph Hospital of Orange
Responsible for providing coordinator assistance for clinical studies in the Office of Research Administration in accordance with Hospital policy and with Good Clinical Practice and ICH guidelines as adopted by the FDA. Responsible for abstracting information from various sources in accordance with specific assigned project guidelines and accurately entering information into Study Manager or other appropriate system. Responsible for training and supervising Clinical Research Coordinators in the Office of Research Administration. Develops collaborative relationships with industry sponsors and SJO physicians. Provides education to physicians regarding research processes and opportunities at SJO.
- High school diploma or equivalent.
- Five years of working experience in a clinical research setting.
- Required (CCRC or CCRP)
- AA or BS degree in biological or clinical sciences.
- Previous hospital experience, experience abstracting or coding information from patient medical records.
- Laboratory skills for the safe operation of standard clinical centrifuge, separation of blood components, skilled handling of biohazardous material, pipeting, use of dry ice and liquid nitrogen for freezing and/or storing clinical samples.
- Time management skills.
- Effective oral and written communication skills.
- Skilled at chart review and abstracting data from patient charts.
- Skilled in finding and abstracting specific, required information from complex documents (e.g. Patient records, study protocols, etc.)
- Competent in MS-Word and MS-Excel applications.
- Interpersonal skills necessary to work effectively with physicians, patients, nursing and ancillary staff in a variety of contact settings.
- Appropriate knowledge of anatomy, physiology, disease process and standard treatment protocols.
- Knowledge of Good Clinical Practice and ICH guidelines as adopted by the FDA.
- Working knowledge of Hospital research policies and procedures, HIPAA guidelines, IRB’s, and FDA regulatory requirements for clinical studies.
- Ability to think critically.
- Demonstrated maturity and capacity to maintain confidential information.
- Demonstrated ability to complete assigned tasks accurately and timely with appropriate training and supervision.
- Ability to take direction and to establish priorities, to self-direct and work independently.
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