CRC Technician/Assistant

Michigan Medicine; Ann Arbor (MI); On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

Excellent medical, dental and vision

2:1 retirement match

Job summary

Michigan Medicine seeks a Clinical Research Coordinator Assistant to independently coordinate simple and moderately complex studies. You will join the CRC team and support a portfolio of projects with varying levels of complexity, following the CRC ladder requirements.

The role includes assisting with IRB submissions, screen and enroll subjects, manage data in CRFs, collect specimens, and report on study progress while maintaining confidentiality and collaboration with sponsors and regulators.

Qualifications

• Associate’s Degree or equivalent in clinical research or related field.
• 1+ years direct related experience OR advanced health-related degree OR 3 years of human subjects experience.
• Underfill option allows High School Diploma with equivalent experience.
• Bachelor’s Degree in Health Science desirable.
• Familiarity with OnCore, Epic, MiCHART and eResearch applications.
• PEERS, CITI, or NIH training certifications are a plus.
• Experience with IRB submissions and regulatory processes.

Responsibilities

• Coordinate clinical research studies with varying complexity under supervision.
• Assist in IRB submissions, amendments, and continuing reviews.
• Screen, consent, enroll subjects and collect study data.
• Manage data entry into Case Report Forms and external records.
• Collect, process, ship, store, and track specimens and lab data.
• Monitor adverse events and assist with safety reporting.
• Liaise with sponsors, IRB, and regulatory agencies as needed.
• Support training of CRC staff and maintain confidentiality.
• Ensure study space, materials, and equipment readiness.

Skills

Clinical research coordination

Communication & teamwork

Regulatory awareness

Education

Associate’s Degree or equivalent in clinical research

High School Diploma or GED

Bachelor’s Degree in Health Science (desirable)

Tools

OnCore

Epic

MiCHART

eResearch

Job description

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Job Summary

This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required.

Responsibilities*

• 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
• Assist study team with aspects of clinical research coordination including: identifying potential subjects, screening subjects, consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects.
• Collect specimens and monitor study subjects. Assist in monitoring of test results. Ensure 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). Assist with collection of external medical records for study reporting purposes. Ability to identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs).
• Prepare IRB submissions including the initial applications, as well as 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. Serve as key resource to research participants and collaborators. 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. There is a need to move, transport, and position clinical research supplies weighing up to 50 pounds across the hospital campus.
• 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.

Required 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

Desired Qualifications*

• 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

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Work Schedule

This position will primarily support work M-F during normal business hours.

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

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.