Clinical Research Technician (with Underfill)

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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

The Department of Psychiatry Mood Disorders Program is seeking a Clinical Research Coordinator to manage day-to-day tasks for research projects and industry sponsored clinical trials in interventional psychiatry. With guidance from senior faculty and research personnel, the clinical subjects coordinator will handle organizational and administrative details of assigned projects. Additionally, the candidate will screen, recruit, and enroll patients from physician clinicians and perform job responsibilities listed below:

Responsibilities*

We seek a Clinical Research Coordinator who will work in a collegial fashion with the principal investigator, research coordinators, administrators, and collaborators on clinical trials in mood disorders, with research funded either by the Patient-Centered Outcomes Research Institute (PCORI) or by commercial sponsors. This role includes coordination and execution of research studies, coordination of patient and laboratory data and the screening, recruitment, and retention of clinical trial participants. You will consult with the principal investigator and research manager on relevant study related issues.
•    Ensure studies are carried out according to the study protocol, SOPs, ICH/GCP and Michigan Medicine regulations and study specific manuals and procedures under the supervision of the PI and Co-I
•    Participate in the development and writing of internal SOPs
•    Screen and recruit study subjects from clinic and MiChart, schedule follow-up appointments, complete study assessments, educate patients and physicians regarding the specifics of each study
•    Act as a liaison between research staff, sponsor and the IRB
•    Collect and process specimens and ship to sponsors
•    Assist PIs in reviewing progress of the studies and evaluating results
•    Maintain database for research studies
•    Review source data and case report forms for accuracy, completeness, and integrity of the data and identifying and resolving ongoing data issues
•    Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitor protocol deviation/exceptions, serious adverse events and laboratory abnormalities and work with PI and research manager to report AE/SAEs, amendments, SCRs, etc.

Required Qualifications*

•    Requires the academic knowledge in a health science, or social science discipline that is generally associated with a Bachelor's degree or an equivalent combination of education and experience
•    Knowledge of Microsoft Windows, Outlook email/calendaring, Dropbox, Excel, PowerPoint, and Electronic Data Capture systems (i.e. REDCap, Qualtrics, Medidata)
•    Previous experience managing data and data analysis (SPSS, SAS, etc.)
•    Willingness to learn and develop additional computer skills related to data management and preparation of data for analysis
•    Outstanding written, verbal communication and organizational skills
•    Attention to detail and accuracy
•    Excellent customer service
•    Ability to handle multiple tasks in a fast-paced office environment with competing deadlines
•    Ability to maintain strict confidentiality
•    Demonstrated ability to work independently as well as cooperatively
•    Familiarity with organization of Michigan Medicine

Desired Qualifications*

•    Clinical experience with mood disorder patients, and experience in working with distressed individuals, including individuals dealing with suicidal ideation
•    At least 6 months experience in administering key diagnostic and symptom rating scales in psychiatry, such as the SCID, MINI, and C-SSRS
•    Knowledge of Michigan Medicine & University of Michigan based systems, including but not limited to MiChart, OnCore, eResearch, REDCap, and PEERRS
•    Ability to work with minimal supervision with diverse teams of physicians, managers, coordinators, collaborators, IRB, and Office of Research and Sponsored Projects in a diplomatic, collaborative, and effective manner
•    Demonstrated problem solving and conflict resolution skills
•    Ability to multi-task, work well under time constraints and meet deadlines

Work Schedule

Monday-Friday, full-time

Work Locations

Michigan Medicine Psychiatry Outpatient - Rachel Upjohn Building & ECT Suite in Main Hospital; Work from home

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

Background Screening

Under Michigan law, a criminal history check including fingerprinting is required as a condition of transfer or employment for this position.

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.


U-M COVID-19 Vaccination Policy

COVID-19 vaccinations, including boosters when eligible, are required for all University of Michigan students, faculty and staff across all campuses, including Michigan Medicine.  This includes those working remotely.   More information on this new policy is available on the Campus Blueprint website or the UM-Dearborn and UM-Flint websites.