Sr. Clinical Research Coordinator Responsibilities
The Senior Clinical Research Coordinator (Sr. CRC) provides support, coordination, and leadership for industry sponsored clinical research, government sponsored clinical research, and investigator initiated clinical research within the Department of Orthopaedic Surgery. This position ensures smooth, accurate progress of clinical studies from the planning and approval stages, through study completion and post-study closure. The incumbent prepares documentation for submission for review by the Institutional Review Board (IRB), recruits and screens study participants, coordinates the clinical treatment and follow-up care as it pertains to study protocol, and facilitates continued participation. The Sr. CRC also abstracts data from medical records and other sources; collects, submits and maintains study data and regulatory documents; develops and ensures compliance with study protocols; and participates in the planning, development and budgeting of clinical studies. The Sr. CRC provides leadership for a department-wide clinical research program, including guiding and mentoring clinical research coordinators, associates, and/or other support personnel.
Sr. Clinical Research Coordinator Qualifications
Society for Clinical Research Associates (SOCRA) Certified Clinical Research Professional (CCRP) or Association of Clinical Research Professional (ACRP) Certified Clinical Research Coordinator (CCRC)
Advanced knowledge of regulatory processes as well as a working knowledge of data management activities.
Advanced-level knowledge of federal, local, and institutional regulatory guidelines.
Thorough knowledge of regulations related to FDA, state & federal guidelines, and Good Clinical Practices, for drug and device studies (clinical research involving human subjects).
Advanced-level knowledge of basic anatomy, medical terminology and ability to interpret physicians' notes, medical records, laboratory and scan results.
Advanced analytical skills to evaluate information, practices and procedures, formulate logical and objective conclusions and make recommendations for effective solutions.
Administrative skills and ability to exercise good judgment, initiative and resourcefulness in making decisions.
Experience and working knowledge of but not limited to: scheduling and medical record systems, Microsoft Word, Excel, Access and etc.
Demonstrate oral and written communication skills, including skills to compose reports and correspondence while utilizing correct grammar, spelling and punctuation as well as clearly documenting research data onto forms.
Advanced-level knowledge and understanding of orthopaedics, orthopaedic diagnosis, disorders and treatments as applied to clinical research.
Leadership skills and mentor experience.
Experience working individually and as a team member in a diverse workforce.
THIS POSITION MAY BE SUBJECT TO A CRIMINAL BACKGROUND INVESTIGATION, DRUG SCREEN, LIVE SCAN FINGERPRINTING, MEDICAL EVALUATION CLEARANCE, AND FUNCTIONAL CAPACITY ASSESSMENT.
Position may require working occasional overtime and traveling between local work locations as work demands. Travel (vehicle or airline) for training and educational purpose may also be required.
THIS IS NOT AN H1B OPPORTUNITY.
To view full job description and submit an on-line application visit UC Davis Career Opportunities at: