Clinical Research Assistant - Term Limit

Clinical Research Assistant - Term Limit Apply Now How to Apply Interested candidates are invited to submit a resume/CV and cover letter outlining their qualifications and interest in the position. Applications will be reviewed on a rolling basis until the position is filled. Up to 3 professional references should be made available upon request. Job Summary This is the entry level position on the Michigan Medicine CRC Career Ladder (https://research.medicine.umich.edu/our-units/clinical-trials-support-office/clinical-research-coordinator-career-ladder) . This position provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies. Our mission is to improve the quality of life of people with pain. Achieving personalized pain management will transform care, while dedication to our guiding principles enriches the lives of our team members and those in the community. Mission Statement Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society. 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 Competitive salary commensurate with experience. Comprehensive healthcare benefits package. Retirement savings plan with employer contribution. Professional development opportunities and support for continuing education. Paid time off and holiday leave. Responsibilities* Knowledge of 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 Clinical Coordinator Responsibilities Demonstrates ability to screen participants for study eligibility & enroll with accuracy in various databases. Performs simple study procedures with accuracy. Understands protocol structure and how to interpret study requirements to ensure study compliance. Understands proper documentation techniques as outlined in the ICH-GCP guidelines. May complete simple study reimbursement with partners such as the Human Subjects Incentive Program (HSIP) and the CTSU finance team. Demonstrates the ability to find and utilize information from EMR and databases/CTMS/EDC. May mark visits as planned/occurred in OnCore. May provide lab results, not interpretation, to participants. May maintain essential regulatory documents. May assist research coordinator in conduct of SIV; attends SIV. May assist in and attends monitor visits and or audits. May conduct site selection/qualification visits for potentially incoming clinical trials. Data Coordinator Responsibilities Demonstrates the ability to complete simple data collection during study visits Enters data to complete forms (CRFs) on paper, databases, or EDCs. Assists with collection of external medical records, CLIAs, CAPs, and radiology CDs as assigned. May administer minimal risk consents, surveys, and questionnaires. Checks own work and confirms accuracy. Demonstrates ability to perform concomitant medications abstraction. Uses various NCI AE grading scales. Builds patient research study charts. Demonstrates ability to resolve simple queries. Regulatory Coordinator Responsibilities May work with regulatory support to collect essential documents and maintain regulatory binder Assists with AEs and SAEs, ORIOS reporting Uses proper documentation techniques as outlined in the ICH-GCP guidelines Administrative Responsibilities Demonstrates understanding of the clinical research objectives associated with the program. May communicate with study participants such as sending study correspondence via mail or email. May schedule subjects for research visits and FU appointments. May check study calendar for completion of study procedures. May manage study supply inventory. May utilize documents and systems to track recruitment and retention of participants. May complete and activate postings (advertisements, flyers, etc.) independently. May work with regulatory support to maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, UM lab norms, etc.) Training Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned. Willing to learn and use available technology and systems to accomplish job requirements. Understands the disease process per program. Attends and participates in all training classes assigned to this level Supervision Received: This position receives direct supervision and reports directly to a CRC-Senior or Research Area Specialist Lead. Supervision Exercised: None Required Qualifications* High school diploma or GED is necessary. Desired Qualifications* Associate Degree in Health Science or an equivalent combination of related education and experience is desirable. An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable. 1+ years of experience in clinical pain research Has previously built forms in REDCap and Qualtrics Experience with investigator-initiated and federally sponsored clinical trials PEERRS, CITI, or NIH Protection of Human Subjects Training Certification Work Schedule The work schedule for this position consists of regular business hours, M-F from 8-4:00pm. There will be Saturday hours once a month. Work Locations Burlington Building, Ste 100, Room 1025. 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. This is a one year term-limited position. Extensions will be based on available funding and performance. At the end of the stated term, your appointment will terminate, and will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct. 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 255546 Working Title Clinical Research Assistant - Term Limit Job Title Clinical Research Assistant Work Location Ann Arbor Campus Ann Arbor, MI Modes of Work Hybrid Full/Part Time Full-Time Regular/Temporary Regular FLSA Status Nonexempt Organizational Group Medical School Department MM Anesthesiology Department Posting Begin/End Date 10/14/2024 - 10/21/2024 Career Interest Research Apply Now