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.

To support the coordination of clinical trials conducted at FNICOMO lab.

25% Clinical Coordinator Responsibilities:
Coordinates multiple studies both independently and as a member of a team
Screens and recruits subjects for several studies
Administers and scores neuropsychological test batteries to assess cognition, memory, and executive function
Evaluates participant motor and sensory functioning pre- and post-study drug intervention
Uses DEXA scanner to obtain bone density images
Trains subjects in the use of study devices. Triages any subject concerns
Monitors that study procedures and CRFs are completed accurately
Coordinates research procedures for complex clinical trials involving multiple MRI, PET, and lab appointments for each subject per study protocol
Utilizes MiChart to order participant imaging and research sample requests. Links orders to research to avoid billing errors
Performs wet lab procedures, such as centrifuging and aliquoting, to process biological specimens for internal and external use
Calculates and submits compensation to HSIP for subjects upon study completion
Creates and manages recruitment and enrollment tracking logs for multiple studies
 

25% Data Coordinator Responsibilities:
Completes complex CRFs in accordance with ALCOA-C principles during study visits
Resolves data queries in CRFs for multiple studies
Develops and edits CRFs for Investigator Initiated trials
Manages the restructuring and maintenance of critical databases to streamline data entry and ensure that enrollment information is accurately stored
Transfers data from CRFs to databases
 

25% Regulatory Coordinator Responsibilities:
Prepares IRB applications, amendments, and continuing reviews
Collaborates with MICHR for INDs in clinical drug trials
Upholds the principles of Good Clinical Practice
Obtains informed consent both virtually using SignNow and in-person
Prepares materials for and participates in study initiation meetings, monitoring visits, and audits
Contributes to regulatory binder maintenance and data safety monitoring including AE and ORIO reporting
Revises and edits protocols and consent forms of varying complexity

15% Administrative Responsibilities:
Identifies potential research subjects using DataDirect, UMHealthResearch, and through community outreach
Communicates with subjects via phone, mail, and email
Schedules subject research visits and follow-up appointments
Adds appointments to the lab calendar
Orders prescription study drugs and maintains inventory logs
Coordinates the shipment of specimens to external sites
Keeps records of investigational drug inventories during clinical trials to maintain accountability and compliance with IRB requirements
Creates recruitment logs to track recruitment and retention
Creates advertisement flyers and study summary sheets for recruitmen

10% Training
PEERS Human Subject Protection, PEERRS RCRS, CITI GCP, HIPAA, Chemical Hygiene, CITI Biosecurity, TMS Infection Control, CTMS, EMR, American Heart Association Basic Life Support, MoCA
Trains new research staff and student workers on test administration, data management and the use of lab equipment

• 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 SoCRA's 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.

• Experience working with patients with neurodegenerative disorders, preferably Parkinson's disease.

• 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
• Previous experience with clinical trial.

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.

Days, M-F, 9am-5pm

Domino's Farms

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.

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 any time after the minimum posting period has ended.

The University of Michigan is an equal employment opportunity employer.