Clinical Research Technician/Clinical Research Assistant - Term Limited

Michigan Medicine; Ann Arbor (MI); Hybrid; USD 55,000 - 75,000; Full time

Benefits offered by this job

Excellent medical, dental and vision

2:1 retirement match

Job summary

Michigan Medicine is seeking a Clinical Study Coordinator-Technician/Assistant to support research analysis and regulatory submissions within the CPFRC in the Department of Anesthesiology. The role collaborates with physicians, biostatisticians, project managers, and data managers on longitudinal cohorts and clinical trials.

The position requires coordination of tasks, compliance with federal/state regulations, and strong data integrity.

Qualifications

• Performs moderately complex study procedures with accuracy
• Ability to work independently but also within a team
• Flexibility to meet project deadlines and goals; strong problem-solving skills
• Adhere to strict confidentiality and maintain detailed records of study procedures
• Experience with Microsoft Office products (Word, Excel, PowerPoint)
• Demonstrated organizational skills and motivation with strong multitasking abilities
• Learn and apply new skills quickly and efficiently
• Commitment to participant privacy and data confidentiality

Responsibilities

• Provide administrative and coordination support for multiple clinical research projects
• Assist with regulatory documents and IRB submissions (amendments, SAEs, ORIOs)
• Build and maintain participant databases for remote data collection and scheduling
• Manage data entry, charts reviews, mailings, and participant incentives
• Attend team meetings and support study activities; travel 5-10% may be required
• Support limited single-center and multi-center studies as needed

Skills

Independent work

Team collaboration

Problem solving

Microsoft Office

Multi-tasking

Data confidentiality

Record-keeping

Education

Associate degree in health science

Advanced degree in health-related field

High school diploma or GED

Tools

OnCore

Epic

MiCHART

REDCap

Qualtrics

eResearch applications

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

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

The Chronic Pain and Fatigue Research Center (CPFRC), located within the Department of Anesthesiology is a collaborative, collegial, and fast paced program that enjoys the opportunity to partner with many researchers from the Schools of Medicine and Public Health, as well as extramural biomedical researchers. The successful candidate for this position will participate in many aspects of research analysis and collaborative activities, with research programs including longitudinal cohorts, cross-sectional studies, clinical trials, health services and translational research with funding from a variety of sponsors including, NIH, industry, and others. The CPFRC provides rich opportunities for career development and continued learning from experienced colleagues. The research team includes physicians, biostatisticians, project managers, study coordinators, data managers, and administrative support.

The Clinical Study Coordinator-Technician is expected to work as part of a collaborative team and is responsible for managing their assigned tasks. They are expected to understand and support the conduct of research within all federal, state, and local regulatory requirements. This position provides administrative and coordination support for multiple projects in the conduct of clinical research projects. Assignments may include tasks for both single-center and multi-center studies.

This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position will help support a portfolio of projects with varying levels of complexity.

Responsibilities

Characteristic Duties And 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

• Provide support to participants around the multiple technological components of research studies and trials, including installing the study smartphone application(s), electronic consenting, and setup of wearable devices, as well as navigating online electronic data capture systems.
• CRC-tech will work with other team members to:
  • organize and reach out to lists of participants that may be contacted for recruitment,
  • Screen, informed consent, and enrollment of participants according to protocol for research studies,
  • track and follow participants in study after their initial enrollment,
  • enter and manage data,
  • conduct chart reviews as necessary,
  • prepare and send participant mailings,
  • support the distribution of participant incentives,
  • provide customer support around participant usage of the studies? technologies
  • perform other routine project tasks.
• Assist with maintaining regulatory documents and assisting with IRB submissions such as amendments, SAEs and ORIOs.
• May assist in the preparation of a variety of reports such as quarterly updates and regulatory.
• Help build and maintain participant databases for remote data collection and participant scheduling, tracking, and monitoring, including resolving data queries
• Attend regular team meetings to discuss, troubleshoot and resolve study activities
• Travel (5-10%) may be required to participant in necessary meetings
• Other duties as assigned

Supervision Received

This position receives direct supervision and reports directly to (a CRC-Lead, CRC-Project Manager, a unit Administrator, Director, or Faculty Principal Investigator).

Supervision

Is received from Project Senior Manager. Administrative supervision is received from the Division Administrator and Project Manager. Staff members in this classification are expected to work independently and regularly exercise judgment in setting priorities, resolving operational problems and the application of policies, procedures and methods, while maintaining the strictest of confidentiality at all times. A very strong work ethic is required with appreciation for the importance of complete and accurate research data and specimen handling.

Supervision Exercised

None.

Required Qualifications

• Performs moderately complex study procedures with accuracy
• Ability to work independently but also within a team
• Job will require flexibility in order to meet project deadlines and goals; therefore, a strong ability to problem-solve is highly desired
• The candidate for this position must also be able to adhere to strict confidentiality guidelines, demonstrate a strong ability to establish rapport with participants, and demonstrate a strong ability to keep accurate and detailed records of all study procedures.
• Experience with Microsoft Office products (i.e., Microsoft Word, Excel, and Power Point)
• Confident and highly motivated with excellent multi-tasking ability and record-keeping skills.
• Outstanding organizational skills with meticulous attention to detail.
• Strong ability to work independently, exercising good judgement, with minimal supervision.
• Demonstrated ability to learn and use new skills quickly and effectively.
• Able to maintain data confidentiality and adhering to participant privacy.

Clinical Research Technician

• 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 SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.) or
• An advanced degree in a health-related areas 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 is necessary.

Desired Qualifications

• 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.
• 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.
• Familiarity with OnCore, Epic, MiCHART, and eResearch applications
• Knowledge and experience with MyDataHelps, REDCap, Qualtrics, and other online databases.
• Community-engagement experience
• Ability to effectively communicate with staff and faculty of all levels
• Knowledge of University policies and procedures

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

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

Work Schedule

This position will be on site to begin and will be eligible for a hybrid work schedule combining remote and in-office work. The position is a 40-hr/week role.

Work Locations

Domino Farms

Underfill Statement

This position may be underfilled at the CRC-Assistant title based on selected candidates, qualifications. In addition to general study activities, this role will deliver structured health coaching sessions as part of research protocols. The Clinical Research Health Coach supports participant engagement, assists with behavioral intervention delivery, and supports the conduct of clinical research studies such as registries, long-term follow-up cohorts, and qualitative research. This position will not independently coordinate clinical trials.

Additional Information

This position is term-limited for about 2 years with the possibility of renewal based on need and available funding. At the end of the stated term, your appointment will terminate and will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct.

This position may require occasional evening or weekend availability to accommodate participant scheduling needs.

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.