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Irb compliance coordinator skills for your resume and career
15 irb compliance coordinator skills for your resume and career
1. FDA
The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.
- Produced reports of detailed FDA panel meeting minutes in conformance with regulatory standards.
- Organized and led study file audits to ensure FDA inspection readiness.
2. CIP
A Capital Improvement Plan (CIP) is a planning tool used to coordinate the timing and financing of capital improvements over a period of several years. It helps organizations make good budget decisions for large projects and purchases based on objectives and resources. The purpose of a CIP is to identify capital improvement projects, identify and forecast funding sources, prioritize improvements based on available funds, and estimate a timeline for completing the improvements.
- Developed and conduct a CIP exam preparation class.
- Certified IRB Coordinator (CIP) through PRIM&R.
3. Research Studies
- Coordinate current and incoming requests for research studies to be done in the hospital following federal guidelines.
- Developed and implemented applied research studies related to the education of medical students.
4. Review Process
- Managed human subjects proposal review process.
- Supported researchers and Board members with Continuing Review process, ensuring that researchers did not lapse in approval.
5. Consent Forms
Consent forms refer to something that a person signs or attests to in order to agree for something that involves them to happen. They are used in various fields and applications. It is a legal document that can have repercussions if forged or denied later. In medical terms, it is the informed consent of the patient agreeing to the medical procedure they are about to undergo in a sound state of mind.
- Reviewed informed consent forms for protocol and amendment-specific content and ensured presence of federally mandated elements of informed consent.
- Provided hands-on guidance to research study teams on protocol and consent form development to ensure compliance with institutional and federal requirements.
6. Informed Consent
- Review informed consent documents for all protocols.
- informed consent, letters) on behalf of the IRB when making approved changes to the document.
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- Provided advice to researchers regarding IRB compliance in clinical trials.
- Communicated extensively with data management in correspondence of data queries Managed the oversight of serious adverse event reporting for clinical trials.
8. Human Subject Research
- Developed extensive knowledge of IRB policies and government regulations in the areas of human subject research protections.
9. Local Regulations
Laws that are limited in application to a particular constituency are called local laws.
- Use of a certain degree of diplomacy in ensuring that all investigators comply with the continually evolving federal and local regulations.
10. Meeting Minutes
- Managed monthly IRB meetings, including meeting agendas, directing and leading meeting discussions, and preparing meeting minutes.
- Transcribed and reported meeting minutes; notified investigators and coordinators of IRB actions and status of trials.
11. Institutional Policies
- Conducted protocol audits and monitoring and confirmed compliance with HRPO requirements and Institutional policies.
- Communicated and interpreted institutional policies to research staff and faculty.
12. Research Community
- Conducted educational sessions for the research community.
- Served as resource to the IRB members and the NU research community on matters of NU IRB Office policies and procedures.
13. Meeting Agendas
- Generated, organized and revised meeting agendas.
- Prepare meeting agendas - assign applications to committee members, send out agenda, and upload pertinent information or documentation.
14. Federal Research Regulations
- Monitored and interpreted federal research regulations and policies, and updates existing institutional policies to ensure continuing compliance with federal guidelines.
15. Preliminary Review
- Conducted preliminary review of all full board submissions for accuracy, completeness, and determined eligibility for expedited review.
- Performed preliminary review of group responses to outcome letters to ensure compliance with CIRB stipulations.
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List of irb compliance coordinator skills to add to your resume

The most important skills for an irb compliance coordinator resume and required skills for an irb compliance coordinator to have include:
- FDA
- CIP
- Research Studies
- Review Process
- Consent Forms
- Informed Consent
- Clinical Trials
- Human Subject Research
- Local Regulations
- Meeting Minutes
- Institutional Policies
- Research Community
- Meeting Agendas
- Federal Research Regulations
- Preliminary Review
- Research Submissions
- Approval Letters
- HIPAA
- Sops
Updated January 8, 2025