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) Intermediate will support the ongoing research and administrative functions within the Department of Surgery, Section of Vascular Surgery. This position will require study coordination for multiple clinical research studies, which will include an in-depth understanding of study protocols to assist with successful implementation of all study requirements. The CRC Intermediate will interact with investigators, research staff, midlevel providers, and study sponsors.
Key attributes for the CRC Intermediate role in the Section include: perform tasks and make decisions independently; ability to troubleshoot and problem-solve; demonstrate excellent interpersonal skills; strong attention to detail; effective written and verbal communication – with the ability to receive and convey information clearly and concisely for various mediums; and strong working relationships with stakeholders, Section Chief and Section Administrator.
The CRC Intermediate 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 Intermediate will be responsible for ensuring that all projects are completed within specifications. Primary activities will include, but not limited to:
Demonstrate understanding of protocol elements/requirements and demonstrate the ability to execute study procedures
Lead participant screening and recruitment for industry sponsored clinical trials, NIH funded studies, and internal funded studies
Coordinate study visits or follow-up interactions, as well as schedule and assist with preparation for initiation meetings, monitor visits, and audits
Development of research procedures, case report forms, and recruitment materials
Act as a liaison between investigators, sponsors, clinical trials office, and other internal and external contacts for the initiation and execution of clinical research
Data Entry and Cleaning
Assist with data collection, data entry, and maintenance of all data related to patient participation in studies
Take an active role in ensuring data quality
Prepare Institutional Review Board submissions including the initial applications, as well as amendments and scheduled continue reviews, progress reports, safety reports, adverse events, and data use agreements
Bachelor’s degree in Health Science or an equivalent combination of related education and experience
Certification isrequired through Association of Clinical Research Professionals (ACRP) as a Certified ClinicalResearch Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical ResearchProfessionals (CCRP) and must be achieved by 01/01/24.After 01/01/24, certification is required within six months of date of hire.
Experience with IRB application process
Experience in safety reporting
Experience in sample collection/handling
Demonstrated understanding of clinical research; understand compliance issues related to human subjects research, knowledge and application 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
Minimum 3 years of directly related experience in clinical research and clinical trials is necessary
Minimum 2 years of of directly related experience in clinical research and clinical trials is necessary
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
6+ years of direct related experience
4+ years of direct related experience
This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.
Michigan Medicine (or unit specific name)is firmly committed to advancing inclusion, diversity, equity, accessibility, andbelonging, which are core to the culture and values of the Medical School Office of Research. Our community supportsrecruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan andthe world. We strive to create a work culture where each team member feels respected, valued, and safe.
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.
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.
U-M COVID-19 Vaccination Policy
COVID-19 vaccinations, including one booster when eligible, are required for all University of Michigan students, faculty and staff across all campuses, including Michigan Medicine. This includes those working remotely and temporary workers. More information on this new policy is available on the U-M Health Response website or the UM-Dearborn and UM-Flint websites.
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.