Clinical Research Coordinator Intermediate

Clinical Research Coordinator Intermediate Apply Now Job Summary This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Associate position on the Michigan Medicine CRC Career Ladder (https://research.medicine.umich.edu/our-units/clinical-trials-support-office/clinical-research-coordinator-career-ladder) is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: design, demonstrate, develop, guide, and support. 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 day 2:1 Match on retirement savings Responsibilities* Expert level knowledge, skills, and abilities within all 8 competency domains is expected: Scientific Concepts and Research Design Ethical Participant Safety Considerations Investigational Products Development and Regulation Clinical Study Operations (GCPs) Study and Site Management Data Management and Informatics Leadership and Professionalism Communication and Teamwork Responsibilities will include, but are not limited to: Assist with the recruitment and retention of subjects, scheduling of procedures, and collection of data. Track research visits ensuring compliance with protocol requirements. Maintain accurate research records and transcribe collected data onto source documents and electronic case report forms. Upload images, request records, and file documents appropriately for audit readiness. Assist with identification, documentation and reporting of adverse events according to standard operating procedures and protocol requirements. Assist with writing, editing, and renewing Institutional Review Board applications; maintain version trackers for IRB applications, informed consent documents, protocol version trackers, and other related items. Assist with budget and billing calendar development and revisions. Review account statements comparing against payment schedule and billing calendar to ensure accuracy.Prepare and submit requests for billing adjustments and invoices as needed. Assures compliance with protocols, adherence to good clinical practice guidelines, FDA regulations, and all other federal, local, and University guidelines. Perform study-specific tests in clinic such as mini-mental, grip test, and walk test. Other duties as assigned or required for the research project. Supervision Received: This position reports directly to the Clinical Research Manager in the Department of Cardiac Surgery. Functional supervision is received from the principal investigators, co-investigators, and the VAD Program Manager. Required Qualifications* Bachelor's 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 3 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. Desired Qualifications* 6+ years of direct related experience. Demonstrated understanding of GCP, ICH, and FDA regulations. Prior experience with Bioresearch Monitoring Program (BIMO) audits including preparatory quality assurance reviews. Work Schedule Hours/Week: This is a full-time position at 40 hours/week. Shift/Hours/Days: Days, occasional evening, potential weekends. Some overnight travel expected for study related meetings and conferences. Modes of Work Positions 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 thework modes (https://hr.umich.edu/working-u-m/my-employment/ways-we-work-resource-center/ways-we-work-implementation-group/modes-work) . Additional Information Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe. Background Screening 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. Application Deadline 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. U-M EEO/AA Statement The University of Michigan is an equal opportunity/affirmative action employer. Job Detail Job Opening ID 255198 Working Title Clinical Research Coordinator Intermediate Job Title Clinical Research Coord Inter Work Location Ann Arbor Campus Ann Arbor, MI Modes of Work Hybrid Full/Part Time Full-Time Regular/Temporary Regular FLSA Status Exempt Organizational Group Medical School Department MM Cardiac Surgery Posting Begin/End Date 10/02/2024 - 10/23/2024 Career Interest Research Apply Now