Clinical Research Technician

Job Summary

The REMEDY team at the University of Michigan (UM) manages the surgical clinical trials for the Department of Cardiac Surgery. The team includes coordinators who work on various types of trials and collaborate with other departments and universities.

Responsibilities

• Experience as part of a team with 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.
• Perform moderately complex study procedures with accuracy.
• Triage simple subject concerns and issues appropriately.
• Audit studies for execution and troubleshoot potential implementation issues.
• Schedule, assist with preparation, and attend study initiation meetings, audits, and monitor visits.
• Complete simple to moderately complex data collection during study visits.
• May assist in CRF development.
• Complete new eResearch applications.
• Maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
• Gather participant approval via informed consent.
• Prepare and participate in internal and external audits.
• Identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events(ORIOs), and understand how to report appropriately.
• Communicate with study participants such as sending study correspondence via mail or email.
• Schedule subjects for research visits and FU appointments.
• Check study calendar for completion of study procedures.
• Utilize documents and systems to track recruitment and retention of participants.
• Gain appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.
• Willing to learn and use available technology and systems to accomplish job requirements.
• Understand the disease process per program.
• Attend and participate in all training classes assigned to this level.
• Assists with training activities of staff and others.
• Perform other related duties as assigned.

Supervision Received

This position reports directly to the Clinical Trial Lead for the Department of Cardiac Surgery. Supervision Exercised: None.

Required Qualifications

• An associate degree in Health Science or an equivalent combination of related education and experience is necessary.
• Minimum 1 year of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA?s Definition of a Clinical Research Professional for qualifying experience prior to applying.)
• Or an advanced degree in a health-related area such as: Health Sciences, Behavioral Sciences, Public Health, HealthCare 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, related community health and wellness, related clinical information, and research.

Desired Qualifications

• A bachelor's 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.

Work Schedule

Hrs/Week: 40 hours
Shift/Hrs/Days: Days, occasional evening, potential weekends, potential on call

Pay

N/A

Schedule

N/A

Benefits

N/A