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.
This person in this position will have responsibility for coordination of clinical trials conducted within the department of psychiatry. Trials conducted in the department include both FDA- and non-FDA-regulated trials, sponsored by industry and the federal government, for the treatment of neuropsychiatric disorders. Clinical trials in psychiatry include interventions with devices and infusions of experimental medications in a hospital setting. The person will work under the direction of a principal investigator, and he/she will have specific responsibilities for 2-3 trials (oversee recruitment, study coordination, maintenance of study records, liaison with sponsors, work with trial monitors, and correspond with the local IRB). Job responsibilities may also include clinical assessment, including diagnostic interviews (Structured Clinical Interview for DSM-IV) and use of rating scales to systematically assess symptoms. Clinical experience with psychiatric populations and previous clinical research experience is preferred.
- Coordinate and carry-out subject recruitment through contacts in local clinics, face-to-face interviews and telephone calls.To include participant education with particular sensitivity to issues of confidentiality and informed consent to participate.
- Perform/oversee screening assessments to determine eligibility for a trial, to include gathering pertinent historical & demographic information, surveys and diagnostic assessments.
- Schedule subject participation and coordinate adherence to study protocol.
- Coordinate study interventions, working with clinical personnel to obtain necessary assessments, blood draws, vital sign measurements, etc.
- Monitor research participants for safety and compliance issues
- Complete appropriate data management of subject information and case report form completion.
- Update and maintain records for compliance with human subject regulations, complete appropriate IRB applications for adverse events, amendments and renewals.
- Work with study sponsor to facilitate protocol amendments, regulatory reporting requirements and visits from monitors.
- Attend and participate at organizational meetings; attend local conferences and presentations in areas relevant to project.
- Supervision of other study personnel may be expected to carry out duties described above.
Bachelor’s degree with experience working in clinical research and experience in the conduct of FDA-regulated clinical trials is strongly preferred, including experience with Good Clinical Practice (GCP)
Clinical experience with psychiatric populations and familiarity with DSM-IV diagnoses are very important. Experience with SCID helpful.
Ability to take initiative in decision-making and problem resolution. S/he must be able to appropriately set priorities and meet deadlines
Strong interpersonal skills and flexibility for work in diverse settings.
Basic computer skills - word processing, internet searches, spread sheets, elementary statistics; additional skills in behavioral data acquisition helpful but not necessary.
Advanced degree in health-related field preferred.
Under Michigan law, a criminal history check including fingerprinting is required as a condition of transfer or employment for this position. 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.
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 openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.
The University of Michigan participates with the federal E-Verify system. Individuals hired into positions that are funded by a federal contract with the FAR E-Verify clause must have their identity and work eligibility confirmed by the E-Verify system. This position is identified as a position that may include the E-Verify requirement.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.