Job Summary
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.
Responsibilities*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 studiesManagement of Internal Review Board submissions and renewalsAdministration of patient reported outcome surveysData collection for prospective clinical studiesData collection for prospectively collected retrospective databasesData management including of prospective study data and retrospective databasesClinical process mappingIntraoperative specimen collectionRequired Qualifications*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.Desired Qualifications*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 skillsAn 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.Work ScheduleMonday - Friday, with variability depending on the needs of study participants.
Work LocationsAnn Arbor, MI
Modes of WorkPositions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.
Background ScreeningMichigan 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.
Application DeadlineJob 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.
U-M EEO/AA StatementThe University of Michigan is an equal opportunity/affirmative action employer.