Research - Laboratory/Non-Laboratory, Staff/Administrative
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 Caring, Teamwork, Integrity, Innovation and 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. 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 your specific interest in the position and outline skills and experience that directly relate to this position.
Collects and manages patient and laboratory data for clinical research projects. Screens and has oversight for the recruitment of subjects, supervises the scheduling of procedures 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. 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.
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.
Requires a Bachelor’s degree in a science or health-related field or equivalent education and experience.
SOCRA or ACRP certification or willingness to obtain certification within first year of employment.
Knowledge of IRB's and regulatory experience.
Experience working with human subjects.
Ability to learn MiChart and other research-related computer programs such as OnCore.
Demonstrated knowledge of medical and research terminology
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.
Minimum of 1-3 years of experience 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.
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. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
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. 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.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 184236
About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.