Clinical Research Technician (Term Limited Position)

Michigan Medicine; Ann Arbor (MI); On-site; USD 52,000 - 73,000; Full time

Job summary

Michigan Medicine, within the University of Michigan Department of Radiology, seeks a Clinical Research Technician to support coordination and implementation of clinical trials in FNICOMO. The role involves coordinating multiple studies, recruiting subjects, administering cognitive assessments, and managing imaging and lab procedures per protocol.

The candidate will work under supervision of laboratory faculty and managers, contributing to data handling, regulatory compliance, and study

Qualifications

• Associate degree in Health Science or equivalent required.
• Minimum 1 year of directly related clinical research experience.
• Alternatively an advanced health-related degree or minimum 3 years of human subject experience.

Responsibilities

• Coordinate multiple studies independently and as part of a team.
• Screen and recruit subjects for studies.
• Administer and score neuropsychological tests to assess cognition.
• Utilize MiChart to order imaging and research samples.
• Ensure CRFs and regulatory binder are accurate and up to date.

Skills

Clinical research

Data management

IRB processes

Study coordination

Education

Associate degree in Health Science

Advanced health-related degree

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 12-month, term-limited Clinical Research Technician position is available in the Functional Neuroimaging, Cognitive, and Mobility Laboratory (FNICOMO) within the University of Michigan Department of Radiology (pdresearch.rad.med.umich.edu). Under the supervision of laboratory faculty and managers, the successful candidate will support the coordination and implementation of clinical trials conducted by the FNICOMO Laboratory.

Responsibilities*

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 recruitment

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

Required Qualifications*

• 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 (