The Clinical Research Coordinator (CRC or 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. This position 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.
Classification as a Senior Clinical Research Coordinator requires the incumbent to have achieved professional certifications in Clinical Research and requires use of advanced-level knowledge and skills to independently coordinate, direct, and follow through in the overall administration and outcome of one or more clinical studies. A Sr. CRC provides leadership for a department-wide clinical research program, including guiding and mentoring clinical research coordinators, associates, and/or other support personnel.
Senior / Clinical Research Coordinator
For Senior CRC level, one of the following designations is required: Society for Clinical Research Associates (SOCRA) Certified Clinical Research Professional (CCRP) or Association of Clinical Research Professional (ACRP) Certified Clinical Research Coordinator (CCRC)
Intermediate to advanced knowledge of regulatory processes as well as a working knowledge of data management activities.
Intermediate to 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).
Intermediate to advanced-level knowledge of basic anatomy, medical terminology and ability to interpret physicians' notes, medical records, laboratory and scan results.
Intermediate to 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.
For Senior CRC level, leadership skills and experience in mentoring less experienced staff.
Intermediate to advanced-level knowledge and understanding of orthopaedics, orthopaedic diagnosis, disorders and treatments as applied to clinical research.
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.
To view full job description and submit an on-line application visit UC Davis Career Opportunities at: