MADC Clinical Research Coordinator Associate

Job Summary The Michigan Alzheimer’s Disease Center (MADC) is an NIH-funded research center focused on conducting and supporting Alzheimer’s disease and related dementia research. A key aim of the center’s research is to work with communities to address disparities in Alzheimer’s disease and related dementias. The center also promotes state-of-the-art care and wellness for individuals and families affected by dementia and increases dementia awareness through education and outreach across the state. MADC is seeking a full‑time Clinical Research Coordinator Associate to join its research team. The work location is onsite at the Michigan Alzheimer’s Disease Center in Ann Arbor and the Michigan Clinical Research Unit (MCRU) at Michigan Medicine. Hours are Monday – Friday, 8 am to 5 pm. Responsibilities Independent 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 Examples of duties a successful candidate in this role will perform are as follows: 30% – Clinical Coordinator Responsibilities Administer paper/pencil and computerized neuropsychological examinations and surveys to research participants at the MADC and at the MCRU for supported clinical trials. Score neuropsychological evaluations. Demonstrate understanding of protocol elements/requirements and execute study procedures. Anticipate and mitigate potential protocol non‑compliance. Describe protocol structure and interpret study requirements to ensure study compliance. Accurately implement protocol procedures. Perform non‑GCP related study management activities. Perform study procedures with minimal supervision. Triage simple subject concerns and issues appropriately. Schedule, prepare for, and attend study initiation meetings, monitor visits, and audits. 30% – Data Coordinator Responsibilities Complete complex data collection during study visits. Document all relevant data used in multiple research studies. Enter electronic data into a secure electronic data capture system database. Document data in accordance with all required protocols, ensuring accuracy. Resolve data queries. 30% – Regulatory Coordinator Responsibilities Explain and perform study operational activities in compliance with GCP. Explain proper documentation techniques as outlined in ICH‑GCP guidelines. Identify and report Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs). Collaborate with the Office of Research Compliance Review to create and post studies in ClinicalTrials.gov and obtain the NCT. Assist with investigator‑initiated studies per university and federal guidelines. Maintain essential regulatory documents as outlined in ICH‑GCP guidelines. Explain investigational product development process and key regulations. 5% – Administrative Responsibilities Assist with creating posters, abstracts, and articles. Participate in regular study meetings and complete payment forms for participants. Work collaboratively with MADC, Neurology, and Neuropsychology clinical trials teams. Perform general office and administrative duties as assigned. 5% – Training Complete all training requirements for the previous level. PEERRS, HIPAA, CITI GCP, eRPM Regulatory training. Attend and participate in all training assigned to this level. Required Qualifications Clinical Research Coordinator – Associate Bachelor’s Degree in Health Science or equivalent in combined education and clinical research experience. Certification required through ACRP as a Certified Clinical Research Coordinator (CCRC) or through SOCRA as a Certified Clinical Research Professional (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and must complete or pass the certification within six months of hire. Minimum 2 years of directly related experience in clinical research and clinical trials. Clinical Research Coordinator – Technician Associate Degree in Health Science or equivalent combination of related education and experience. One of the following: Minimum 1 year of directly related experience in clinical research and clinical trials. An advanced degree in a health‑related area such as Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD. Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, community health and wellness, or research. Desired Qualifications Experience working with older adults with or without memory loss. Experience with electronic data entry in REDCap or another platform. Working knowledge of medical terminology and assessment of laboratory values. PEERRS or CITI Program certified. Knowledge of Michigan Medicine policies and procedures. U‑M EEO Statement The 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. #J-18808-Ljbffr Myana