How to Apply
We, the staff and faculty of the Frankel Cardiovascular Center (FCVC) team, are committed to advancing medicine and serving humanity through living and teaching our core values of Respect and Compassion; Collaboration; Innovation; and Commitment to Excellence.
Each FCVC employee is expected to understand and demonstrate that in every interaction we represent our entire organization in the care we provide and in the courtesies we extend to patients, families, and each respective team member. The FCVC is dedicated to partnering with patients and families to deliver the safest and highest quality of health care. Applicants are expected to review the following PowerPoint presentation which provides an overview of the Frankel Cardiovascular Center’s philosophy and culture:
Excellent service is an expected and integral part of the FCVC culture. To be considered for this position, a cover letter is required and should be attached as the first page with your resume. The cover letter should address each of the following points in 50 words or less:
- Describe your background and qualifications and why you believe you would be a good fit for this position at the FCVC.
- Outline your service excellence, communications and event planning skills and experiences which would be applicable to this position.
- In your most recent position, how was service excellence emphasized?
- Describe a situation in which a customer or colleague was upset and the steps you took to resolve the issue to a reasonable conclusion.
- Describe your key impressions of the FCVC presentation.
Collects and manages patient and laboratory data for clinical research projects. Screens and has oversight for the recruitment of subjects, supervises the scheduling of experiments and the collection, processing and analysis of data. Collects specimens and monitors subjects. Assists in the reporting of test results. Employees in this classification typically analyze, compare and evaluate various courses of action and have the authority to make independent decisions on matters of significance, free from immediate direction, within the scope of their responsibilities. Primary activities and decision making authority are predominantly performed independently affecting business operations to a substantial degree. Under FLSA, incumbents in this position meet the criteria for exempt status.
- Assist with the recruitment and retention of subjects, scheduling of procedures, and collection of data.
- Track visits ensuring compliance with protocol requirements.
- Maintains accurate research records and transcribes collected data onto source documents and electronic case report forms. Upload images, request records, and file documents appropriately for audit readiness.
- Assist with identification, documentation and reporting of adverse events according to standard operating procedures and protocol requirements.
- Assists with writing, editing, and renewing Institutional Review Board applications; maintain version trackers for IRB applications, informed consent documents, protocol version trackers, and other related items.
- Assist with budget and billing calendar development and revisions. Review account statements comparing against payment schedule and billing calendar to ensure accuracy. Prepare and submit requests for billing adjustments and invoices as needed. Maintain revenue tracker and assist with budget forecasting.
- Assures compliance with protocols, adherence to good clinical practice guidelines, FDA regulations, and all other federal, local, and University guidelines.
- Perform study-specific tests in clinic such as mini-mental, grip test, and walk test.
- Other duties as assigned or required for the research project.
- Some weekend coverage hours are anticipated during study enrollment period.
- Some overnight travel expected for study related meetings and conferences.
- Requires Bachelor degree in a science or health-related field or equivalent education and experience.
- Certification through ACRP or SOCRA or willingness to become certified.
- Demonstrated knowledge of medical and research terminology and familiarity in heart disease.
- Knowledge of preparation of regulatory documents for clinical trials for submission to IRB (eResearch).
- Ability to work with minimal supervision with diverse teams of people in a diplomatic, collaborative and effective manner.
- Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
- Exceptional organizational and computer skills are required with proficiency in Microsoft software applications.
- Demonstrated problem solving and conflict resolution skills.
- Ability to multi-task, work well under time constraints and meet deadlines.
- Demonstration of commitment to FCVC Core Values.
- Previous experience of 1-2 years with coordination and management of device trials (IDE and HDE) desired.
- Demonstrated understanding of GCP, ICH, and FDA regulations.
- Prior experience with Bioresearch Monitoring Program (BIMO) audits including preparatory quality assurance reviews.
- Previous experience with research related documentation and review in a version of EPIC.
This is a two-year, term-limited position that may be extended based on availability of research projects and funding. If the appointment is not extended, the appointment will terminate and will not be eligible for Reduction in Force (RIF) benefits.
Functional supervision is received from the principal investigators, co-investigators, and project manager. This position will work in collaboration with the project manager and other study team members. Administrative supervision is received from the FCVC VAD Program Manager.
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.
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.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.