Clinical Research Coordinator — Study Ops & Data

University of Michigan; Ann Arbor (MI); On-site; USD 52,000 - 68,000; Full time

Benefits offered by this job

Excellent medical, dental and vision -

2:1 retirement match

Job summary

The University of Michigan's Michigan Medicine is seeking a Clinical Research Coordinator Assistant to independently support study coordination for simple to moderately complex clinical trials. You will join a coordination team and contribute across the portfolio under the CRC Career Ladder, mastering duties and ensuring data quality and participant safety.

Responsibilities include screening and enrolling subjects, IRB submissions, data management, and collaboration with sponsors, IRB, and

Qualifications

• Associate’s Degree or equivalent in combined education and clinical research experience.
• Minimum of 1+ years direct related experience OR advanced degree in health-related areas OR 3 years of related human subjects experience
• Underfill requirement
• High School Diploma or GED
• Bachelor’s Degree in Health Science or an equivalent combination of related education and experience is desirable
• An understanding of medical terminology preferred
• 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
• Motivated to help others

Responsibilities

• Assist study team with identifying potential subjects, screening subjects, consenting and enrolling subjects.
• Collect and manage patient and laboratory data for clinical research subjects.
• Prepare IRB submissions including initial applications, 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.
• 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.
• 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.

Skills

Scientific Concepts and ResearchDesign

Ethical Participant Safety Consider-

Investigational Products Development-

Clinical Study Operations (GCPs)

Study and Site Management

Data Management and Informatics

Leadership and Professionalism

Communication and Teamwork

Education

Associate’s Degree or equivalent in combined education and clinical research experience

High School Diploma or GED

Bachelor’s Degree in Health Science

Tools

OnCore

Epic

MiCHART

eResearch applications

PEERS

CITI Training

Job description

The University of Michigan's Michigan Medicine is seeking a Clinical Research Coordinator Assistant to independently support study coordination for simple to moderately complex clinical trials. You will join a coordination team and contribute across the portfolio under the CRC Career Ladder, mastering duties and ensuring data quality and participant safety.

Responsibilities include screening and enrolling subjects, IRB submissions, data management, and collaboration with sponsors, IRB, and