Summary

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

The successful candidate will be highly involved in the development of a Biobank of Cardiovascular Diseases. You will work in collaboration with the Cardiovascular Health Improvement (CHIP) project team to provide collection and management of biospecimens and clinical outcome data for research projects, screen and have oversight for the recruitment of research participants, scheduling of assessments, and the collection and processing of data.

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
• Flexible spending accounts
• Prescription Drug Plan
• Mental and emotional health programs
• Child Care Resources
• Life Insurance
• Legal Services Plan
• Retirement Savings Opportunities with 2:1 match and immediate vesting

Responsibilities*

Experience as part of a team with all 8 competency domains is expected:

Assists with the recruitment and retention of research participants, scheduling of assessments, and collection of data (biospecimens and clinical outcomes). Ensure compliance with protocol requirements.

Maintains accurate research records and transcribes collected data onto source documents and electronic case report forms. Upload images, request records, and files documents appropriately for audit readiness.

Manages lab policies and procedures.

Research database management and support.

Assists with the oversight of biospecimens including tissue, plasma, serum, and DNA samples.

Assist with preparing biospecimens for investigator-initiated projects.

Performs study-specific assessments during clinic visits or other UMHS visits.

Assists with identification, documentation, and reporting of adverse events according to standard operating procedures and protocol requirements.

Assists with writing, editing, and renewing Institutional Review Board applications; maintain version trackers for IRB applications, informed consent documents, protocol version trackers, and other related items.

Ensures compliance with protocols, adherence to good clinical practice guidelines, FDA regulations, and all other federal, local, and University guidelines.

Other duties as assigned or required for the research project.

Required Qualifications*

• Certification through ACRP or SOCRA or willingness to become certified.
• Ability to work with minimal supervision with diverse teams of people in a diplomatic, collaborative, and effective manner.
• Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
• Exceptional organizational and computer skills are required with proficiency in Microsoft software applications.
• Demonstrated problem solving and conflict resolution skills.
• Ability to multi-task, work well under time constraints and meet deadlines.
• Demonstration of commitment to FCVC Core Values.

Clinical Research Technician:

• Associate’s 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 OR
  • An advanced degree (Masters/above) in a health-related area such as:Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD OR
  • 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.

Clinical Research Assistant:

• High School Diploma or GED

Desired Qualifications*

• Demonstrated knowledge of medical and research terminology and familiarity in cardiovascular disease and its pathway.
• Experience with collecting patient and laboratory data.

• Previous experience in laboratory setting with laboratory policies and procedures.

• Familiarity with internal University processes and programs (MiChart, REDCap, eResearch).

• Proven data entry accuracy and efficiency.

• Previous experience with biobank/biorepository.

Clinical Research Technician:

• Bachelor’s degree or equivalent in combined education and clinical research experience.

Clinical Research Assistant:

• Associate’s Degree or equivalent combination of education and experience.

Work Schedule

Full-time, 40 hours per week. Work hours vary depending on need.

Work Locations

Frankel Cardiovascular Center Room 2336

MSRBIII

Off-sites, as needed

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.

Vaccine Requirements

COVID-19 vaccinations are required for all students, faculty and staff working in the following areas: Michigan Medicine including the Medical School, Dental School, University Health Service or the Mary A. Rackham Institute. This includes those working remotely and temporary workers. More information on this new policy is available on the U-M Health Response.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.