"Clinical Research Technician"

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 Data Direct, UM Health Research, 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

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

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
• Previous experience with clinical trial.

Days, M-F, 9am-5pm