Clinical Research Coordinator

About This Role

This Clinical Research Coordinator position involves providing study coordination for multiple clinical research studies, ranging from moderate to complex, within Michigan Medicine. The role requires independent decision-making, high-quality work, and the ability to apply skills across various study types.

Responsibilities

• Assist study team with aspects of clinical research coordination including identifying, screening, consenting, and enrolling subjects
• Collect and manage patient and laboratory data for clinical research subjects
• Collect specimens and monitor study subjects, ensuring 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)
• Identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs)
• Prepare IRB submissions including initial applications, amendments, continuing reviews, progress reports, safety reports, and adverse event reports
• Communicate with sponsors concerning progress of clinical trials, billing calendar/budget issues, subject related problems, and recruitment strategies
• Act as liaison between study team and sponsors, IRB, federal, state, and university officials and other regulatory agencies
• Provide support for audits and monitor visits
• Prepare and organize space for study related materials and equipment
• Mentor and train other CRC staff through formal and informal presentations

Requirements

• Bachelor's degree in Health Science or equivalent (Associate's or High School Diploma/GED for Technician/Assistant roles)
• Certification (CCRC or CCRP) required, or eligible to register/take exam at hire and complete within six months
• Minimum 2 years of directly related experience in clinical research and clinical trials (Associate specific)
• Minimum 1 year of directly related experience in clinical research and clinical trials (Technician specific)
• High school diploma or GED (Assistant specific)

Qualifications

• Bachelor's degree in Health Science or an equivalent combination of related education and experience (Associate's or High School Diploma/GED for Technician/Assistant roles)
• Minimum 2 years of directly related experience in clinical research and clinical trials for Associate level; 1 year for Technician; None specified for Assistant.

Nice to Have

• 4+ years of direct related experience

Benefits

Certifications