Clinical Research Coordinator Associate

Job SummaryThis position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the Clinical Research Technician position is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.Independent knowledge, skills, and abilities within all 8 competency domains is expected1. Scientific Concepts and Research Design2. Ethical Participant Safety Considerations3. Investigational Products Development and Regulation4. Clinical Study Operations (GCPs)5. Study and Site Management6. Data Management and Informatics7. Leadership and Professionalism8. Communication and TeamworkResponsibilities*50% Clinical Coordinator Responsibilities ex.:Performs non-GCP related study management activitiesPerforms study procedures with minimal supervisionSchedules, assists with preparation for, and attends study initiation meetings, monitor visits, and audits10% Regulatory Coordinator Responsibilities ex.:Form completion and reporting to external governing bodies such as the FDADemonstrating an understanding of the elements of subject safety, related documentation, and reporting20% Data Coordinator Responsibilities:Enters data to complete forms.10% Training:PEERRS, HIPAA, CITI GCP10% Administrative Responsibilities:Creates documentation materials for studiesRequired Qualifications*Bachelors degree in Health Science or an equivalent combination of related education and experience is necessary.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 prior to applying.)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 for qualifying experience prior to applying.)Why Join Michigan Medicine?Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.What Benefits can you Look Forward to?Excellent medical, dental and vision coverage effective on your very first day2:1 Match on retirement savingsModes 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 any time after the minimum posting period has ended.U-M EEO StatementThe University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.