Clinical Research Technician

Responsibilities

• Assist the study team with clinical research coordination, including subject identification, screening, consenting, and enrollment.
• Collect, process, and manage patient specimens and laboratory data, ensuring specimen integrity through proper labeling and storage.
• Perform data management tasks such as entering information into Case Report Forms (CRFs) and collecting external medical records.
• Identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs).
• Prepare IRB submissions, including initial applications, amendments, continuing reviews, and safety reports.
• Act as a liaison between the study team, sponsors, IRB, and regulatory agencies to maintain communication regarding costs and policy changes.
• Support audits and monitor visits while maintaining strict participant confidentiality.
• Organize and prepare space for study-related materials and equipment.

Requirements

• Associate's Degree or equivalent in combined education and clinical research experience.
• Minimum of 1+ years of direct related experience, OR an advanced degree in a health-related area, OR 3 years of related human subjects experience.

Preferred Qualifications

• Bachelor's Degree in Health Science or an equivalent combination of related education and experience.
• Understanding of medical terminology.
• Knowledge of Michigan Medicine policies and practice.
• Familiarity with OnCore, Epic, MiCHART, and eResearch applications.
• PEERS, CITI, or NIH Protection of Human Subjects Training Certification.
• Experience with local and central IRB application processes.

About the Company

The University of Michigan is a leading research institution dedicated to advancing medical science and improving patient care through rigorous clinical trials and innovative research methodologies.