Clinical Research Assistant - Term-Limited

How to Apply

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.

Summary

This is an entry level position that provides administrative and coordination support for multiple projects in the conduct of Clinical Research projects. This position may assist with study coordination but will not be assigned clinical trials independently. This position may provide coordination for Clinical Research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies.

The NIH-funded Michigan Diabetes Research Center's Clinical Research Unit (MDRC-CRU) provides support to MDRC investigators for approved research studies.

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

Responsibilities*

CHARACTERISTIC DUTIES AND RESPONSIBILITIES

Knowledge of all 8 competency domains is expected and experience within applicable domains specific to unit needs.

• 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

Clinical Coordinator Responsibilities

• Perform simple to moderately complex study procedures, including phlebotomy and laboratory procedures, with accuracy
• Understand protocol structure and how to interpret study requirements to ensure study compliance.
• Understand proper documentation techniques as outlined in the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) (ICH-GCP) guidelines.
• Demonstrate the ability to find and utilize information from the electronic medical record (EMR) and databases/Clinical Trial Management Systems/Electronic Data Capture (CTMS/EDC).
• Address participant concerns and issues
• Assess studies for execution and troubleshoot potential implementation issues
• Schedule, assist with preparation, and attend study visits
• Complete simple to moderately complex data collection during study visits
• Assist with local quality control efforts

Data Coordinator Responsibilities

• Complete simple to moderately complex Case Report Forms (CRFs)
• Resolve simple queries
• Assist in CRF development
• Check your own work and confirms accuracy
• Build patient research study charts

Regulatory Coordinator Responsibilities

• Maintain essential regulatory documents as outlined in the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines
• Prepare and participate in internal and external audits
• Identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs)

Administrative Responsibilities

• Understand the Clinical Research objectives associated with the program
• Communicate with study participants (no results interpretation)
• Schedule participants for research visits and follow-up appointments
• Check study calendar for completion of study procedures
• Manage supply inventory
• Utilize documents and systems to track study visits
• Complete and activate postings (advertisements, flyers, etc.)
• Maintain regulatory documents (Curriculum Vitas, physician licenses, lab certifications, IRB rosters, UM lab norms, etc.)

Training

• PEERRS, HIPAA, CITI GCP
• EMR, CTMS, EDC, databases, etc. as assigned
• Assist with training activities of staff and others

SUPERVISION RECEIVED This position receives direct supervision and should report directly to the MDRC-CRU Administrative Manager.

SUPERVISION EXERCISED :None

Skills You Have

• Ability to write and follow protocols
• Good communication skills, reliability, and ability to work independently
• Strong organizational skills

Required Qualifications*

High school diploma or GED is necessary.

Desired Qualifications*

Associate 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

Work hours are 7am to 11am Monday through Friday, depending on the needs of the clinic. Some work shifts may occasionally occur on Saturdays or Sundays.

Work Locations

This position is located in Ann Arbor at Dominos Farms Lobby M. Some work may take place at the main hospital and at the Kellogg Eye center.

Additional Information

We are seeking a dynamic staff member with a excellent organizational skills commitment to contributing to a diverse, equitable and inclusive environment for all members of our community

This position is term-limited for 1 year 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.

Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.

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/AA Statement

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