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 Frankel Cardiovascular Center (FCVC) is seeking to develop future clinical research professionals through the Clinical Research Coordinator Advancement Program (RCAP). Professionals in this role will, through an extensive two-year hands-on experience, develop a strong foundation and advanced skills within their clinical research background through an accelerated classroom curriculum while concurrently providing administrative and research coordination support for a broad range of research projects within Michigan Medicine. Through depth of experience gained in this accelerated environment, applicants will qualify for on-ramp career advancement within our institutional career ladder, post-graduation from the program. Work performed, in addition to education and training, will focus the eight competencies of clinical research enumerated below:
1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork
This program has a robust curriculum that will involve hands on research activities and assignments to accomplish all noted activities listed below. Incumbents in this role will perform a broad range of clinical research responsibilities, notably with close supervision from senior clinical research professionals and the program manager for the RCAP program to confirm work was done appropriately and in alignment with institutional research standards. At the end of the program, incumbents in this role will be prepared for and have experience necessary to sit for professional accreditation for clinical research coordination.
Why Join Michigan Medicine?
Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world?s most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.
What Benefits can you Look Forward to?
- Excellent medical, dental and vision coverage effective on your very first day
- Flexible spending accounts
- Prescription Drug Plan
- Mental and emotional health programs
- Child Care Resources
- Life Insurance
- Legal Services Plan
- Retirement Savings Opportunities with 2:1 match and immediate vesting
Responsibilities*
- Executes standard participant recruitment methods, including screening participants for study eligibility, accurate enrollment in various databases, and handling simple study reimbursements with partners. Provide lab results (no interpretation) to participants and employ creative recruiting tactics and solutions.
- Performs study procedures with precision, maintaining accuracy throughout.
- Demonstrates a comprehensive understanding of protocol structure and the ability to interpret study requirements, ensuring strict study compliance.
- Proficiently accesses and utilizes information from electronic medical records (EMR), MiChart, and various databases, Clinical Trial Management Systems (CTMS), and Electronic Data Capture (EDC) systems.
- Ensures the completeness and accuracy of essential regulatory documents.
- Collects research blood samples, processes, stores, labels, and ships them according to the requirements of each individual clinical trial, ensuring sample quality.
- Accurately enters data into various formats, including paper, databases, and Electronic Data Capture (EDC) systems, to complete Case Report Forms (CRFs).
- Effectively documents and reports Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Occurrences (ORIOs).
- Adheres to proper documentation techniques in compliance with the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines.
- Provides comprehensive administrative support for study activities, including tasks such as document scanning, filing, and related activities.
- Schedules research visits and follow-up appointments for study subjects, ensuring timely and efficient coordination.
- Collaborates with regulatory support to maintain the regulatory binder, including items such as Curriculum Vitae (CVs), medical licenses, lab certifications, Institutional Review Board (IRB) changes, University of Michigan (UM) lab norms, and more.
- Attends and completes all training and course material.
- Acquires essential training and knowledge in areas such as PEERRS, HIPAA, ICH, GCP, and more.
- Perform other related duties as assigned.
Required Qualifications*
- Associate's degree (or expected before June 2024) is required.
- Willingness to obtain accreditation through ACRP or SOCRA at the conclusion of the program.
Desired Qualifications*
- Bachelor's degree (or expected before June of 2026) is desired due to this program's intent to provide a pathway for advancement on the institutional career ladder which at a future point will require bachelor's degree.
- 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.
Work Schedule
This position is full-time (40 hours per week). Occasional nights and weekends may be required to meet the needs of a diverse patient population. This position will be fully onsite.
Additional Information
This two-year Clinical Research Coordinator advancement program will commence on Tuesday, May 28, 2024.
Please visit the following webpage for more information about this exciting opportunity:
https://sites.google.com/umich.edu/fcvc-rcap/home
Background Screening
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.
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.