Clinical Research Coord Assoc - Military Veterans

The Division of Head and Neck Oncology is seeking a highly motivated Clinical Research Coordinator Associate to work alongside surgeon scientists performing clinical and health services research. This position will serve as study coordinator for multiple clinical research studies. Duties and responsibilities of this position involve research participant interaction and management of day-to-day study activities. This individual will work with faculty and clinical staff to enroll study participants, collect and manage data, and support day-to-day operations of the research, as well as assist in the performance and progress of health services research. This position is intended to work independently to facilitate progress on multiple clinical research projects under the guidance of the principal investigator clinician scientists.

Independent knowledge, skills, and abilities within all 8 competency domains is expected:

1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork

Responsibilities:

• Patient enrollment to clinical studies
• Management of Internal Review Board submissions and renewals
• Administration of patient reported outcome surveys
• Data collection for prospective clinical studies
• Data collection for prospectively collected retrospective databases
• Data management including of prospective study data and retrospective databases
• Clinical process mapping
• Intraoperative specimen collection

• Bachelor's degree in Health Science or an equivalent combination of related education and experience.
• Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP )
• Minimum 2 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.

• Training including PEERRS, HIPAA, CITI GCP, eRPM Regulatory training are preferred. Participates in all training related to this level is preferred.
• Experience with REDCap.
• Experience with clinical data management.
• Experience enrolling patients and providing informed consent.
• Experience administering patient surveys.
• Experience with clinical studies (not necessarily clinical trials).
• Statistics and coding skills
• An understanding of medical terminology, experience in large complex health care setting.
• Ability to effectively communicate with staff, patients.
• Knowledge of university policies and procedures is desirable.

Monday - Friday, with variability depending on the needs of study participants.

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.