Details
Posted: 10-May-22
Location: Ann Arbor, Michigan
Salary: Open
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
The Clinical Research Coordinator (CRC) will plan, organize and coordinate aortic and vascular human subject research within the Department of Surgery, Section of Vascular Surgery. This position requires working knowledge of protocol requirements and good clinical practices as set forth by federal regulations. The CRC will interact with investigators, research staff and midlevel providers. As a member of the research team, the coordinator will be knowledgeable of, and assist with, protocol-required therapy and procedures, assessments and ensuring protocol compliance.
Key attributes for the CRC role in the Section include: ability to independently manage work load; troubleshoot and problem solving skills; demonstrated excellent interpersonal skills; strong attention to detail; effective written and verbal communication; and strong working relationships with stakeholders, Section Head and Section Administrator.
The CRC is currently a part-time position (20 hours/week) with the potential to grow contingent on future funding.
The CRC will maintain oversight of the coordination and execution of human subjects clinical research projects within the Section of Vascular Surgery. Primary activities are performed independently, with minimal supervision, and the CRC will be responsible for ensuring that all projects are completed within specifications. Primary activities will include, but not limited to:
- Recruitment, instruction, and coordination of research subjects and study-specific visits
- Acting as a liaison between investigators, research teams, sponsors, other universities, cooperative groups, and other internal and external contacts for the initiation and execution of clinical research
- Provides input on feasibility of new studies (workflow, resources, populations), in conjunction with the Heart, Vessel, Blood Clinical Trial Support Unit
- Development of research procedures, case report forms, and recruitment materials
- Design work flow and develop quality assurance processes
- Collection and maintenance of all data related to patient participation in studies
- Documents and reports all adverse events per protocol and IRB reporting guidelines
- Responsible for the writing of initial IRB applications, amendments, renewals and terminations, as well as data use agreements
- Acts on behalf of patients to ensure care is safe and appropriate with consideration to values, diversity, and human rights
- Maintains/operates research equipment
- Supervisor Undergraduate Research Opportunity Program (UROP) students
- Bachelor’s degree in a science or health-related field, or equivalent education and experience
- One year of clinical research experience; two or more years preferred
- Experience with IRB application process
- ACRP or SOCRA certification within one year of hire
- Experience with safety reporting
- Experience with sample collection/handling
- Demonstrated understanding of clinical research; understand compliance issues, knowledge of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP) and FDA regulations
- Demonstrated understanding of some medical terminology is required
- Demonstrated ability to work autonomously in study management
- Ability to work collaboratively with other disciplines in the management of clinical subjects
- Essential to be proficient in computer programs including word processing, spreadsheets and databases
- Demonstrated excellent writing and communication skills
- Strong organizational skills with attention to detail and a willingness to learn new skills
- 3+ years of relevant experience
- Master’s degree in a science or health-related field, administration, or clinical research administration
- Knowledge of UMHS policies and practices
- ACRP or SOCRA certification
- Experience with internal and external audits
- PEERRS and CITI Training
- Experience with cardiovascular device and drug trials
- Experience with project management
- Experience with OnCore and eResearch
- Experience with REDCap
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
The University of Michigan is an equal opportunity/affirmative action employer.
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COVID-19 vaccinations, including boosters when eligible, are required for all University of Michigan students, faculty and staff across all campuses, including Michigan Medicine. This includes those working remotely. More information on this new policy is available on the Campus Blueprint website or the UM-Dearborn and UM-Flint websites.
