This position will act as a key team member of the clinical research function in the Department of Orthopaedic Surgery. Clinical Research Coordinators (CRC) provide support, coordination and leadership for industry sponsored clinical research, government sponsored clinical research and investigator initiated clinical research. These positions ensure smooth, accurate progress of clinical studies from the planning and approval stages, through study completion and post-study closure. Incumbents prepare documentation for submission for review by the Institutional Review Board (IRB), recruit and screen study participants, coordinate the clinical treatment and follow-up care as it pertains to study protocol, facilitate continued participation; abstract data from medical records and other sources; collect, submit and maintain study data and regulatory documents; develop and ensure compliance with study protocols; and participate in the planning, development and budgeting of clinical studies.
Under the direction of Principal Investigators, the incumbent is responsible for daily study activities and plays a key role in the study conduct and management. The incumbent is responsible for organizing the documentation and files pertaining to studies and for coordinating activities of investigators and study participants. This position requires the use of skills to independently coordinate and follow through in overall administration and outcome of clinical studies.
Senior Clinical Research Coordinators have achieved professional certifications in Clinical Research and are expected to independently manage large complex studies. This level 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. The incumbent will provide leadership for a department-wide clinical research program, including guiding and mentoring clinical research coordinators, associates, and/or other support personnel.
Required Qualifications
Applicants are encouraged to upload license and certification if required of the position.
Certification by the Society of Clinical Research Associates (SOCRA) Certified Clinical Research Professional (CCRP) or the Association of Clinical Research Professionals (ACRP) Certified Clinical Research Coordinator (CCRC) - OR within 12 months of hire.
Experience and working knowledge of but not limited to: scheduling and medical record systems, Microsoft Word, Excel, Access and etc.
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 and 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.
Writing skills to compose reports and correspondence while utilizing correct grammar, spelling and punctuation as well as clearly documenting research data onto forms.
Knowledge of basic anatomy and medical terminology.
Demonstrate oral communication and interpersonal skills for effective, positive and congenial interactions and correspondence with the general public, co-workers, physicians, patients, caregivers, clinic staff, and other health care professionals.
Display organizational skills and attention to detail so that large volumes of records can be accurately maintained and workload priorities can be determined in an appropriate way to accomplish a task or goal.
Ability to multi-task and proactively communicate status of work.
Preferred Qualifications
Experience working individually and as a team member in a diverse workforce.
Intermediate to Advanced-level knowledge and understanding of orthopaedics, orthopaedic diagnosis, disorders and treatments as applied to clinical research.
Leadership skills and experience in mentoring less experienced staff.
Intermediate knowledge of basic anatomy and medical terminology.
Special Requirements
Position may require working occasional overtime and traveling between local work locations, as work demands.
This position may be subject to a criminal background investigation, drug screen, Live Scan fingerprinting, medical evaluation clearance, and functional capacity assessment.
The University of California has implemented a SARS-CoV-2 (COVID-19) Vaccination Program SARS-CoV-2 Vaccination Policy (ucop.edu) covering all employees. To be compliant with the policy, employees must submit proof of vaccination or a University-approved exception or deferral.
To view full job description and submit an on-line application visit UC Davis Career Opportunities at:
