CRC Technician/Assistant

Job SummaryThis position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required.Responsibilities*Experience as part of a team with all 8 competency domains is expected:Scientific Concepts and Research DesignEthical Participant Safety ConsiderationsInvestigational Products Development and RegulationClinical Study Operations (GCPs)Study and Site ManagementData Management and InformaticsLeadership and ProfessionalismCommunication and TeamworkAssist study team with aspects of clinical research coordination including: identifying potential subjects, screening subjects, consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects.Collect specimens and monitor study subjects. Assist in monitoring of test results. Ensure integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc.).Perform data management and results reporting, such as entering information into Case Report Forms (CRFs). Assist with collection of external medical records for study reporting purposes. Ability to identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs).Prepare IRB submissions including the initial applications, as well as amendments and scheduled continuing reviews, progress reports, safety reports, and adverse event reports.In coordination with other M-CTSU staff, communicate with sponsors concerning progress of clinical trials, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures.Act as liaison between study team and sponsors, IRB, federal, state, and university officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues. Serve as key resource to research participants and collaborators. Provide support for audits and monitor visits.Work collaboratively with the M-CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients and families.Prepare and organize space for study related materials and equipment.The person in this position will frequently traverse around the medical campus and will occasionally spend long hours (full days) on their feet. There is a need to move, transport, and position clinical research supplies weighing up to 50 pounds across the hospital campus.Staff members are expected to work independently and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while always maintaining the strictest of confidentiality.This person may help mentor and train other CRC staff through formal and informal presentations.Other administrative responsibilities as assigned.Required Qualifications*Associate’s Degree or equivalent in combined education and clinical research experienceMinimum of 1+ years direct related experience OR advanced degree in health-related areas OR 3 years of related human subjects experienceUnderfill requirementHigh School Diploma or GEDDesired Qualifications*Bachelor’s Degree in Health Science or an equivalent combination of related education and experience is desirableAn understanding of medical terminology preferredKnowledge of Michigan Medicine policies and practiceFamiliarity with OnCore, Epic, MiCHART, and eResearch applicationsPEERS, CITI, or NIH Protection of Human Subjects Training CertificationExperience with local and central IRB application processesMotivated to help othersWhy 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 savingsWork ScheduleThis position will primarily support work M-F during normal business hours.Underfill StatementThis position may be underfilled at a lower classification depending on the qualifications of the selected candidate.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 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. University of Michigan Flint