Frankel CVC Clinical Research Assistant

at  University of Michigan

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.

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.

• 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.