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RssRegulatory Affairs - Clinical Research

I am looking to return to the Regulatory Affairs/Institutional Review Board (IRB) arena in Clinical Research. The majority of my research experience is in Human Subjects Research Protections via the IRB/R & D Committee. Although my experience in regulatory affairs is not as extensive, I am looking to connect with Clinical Research Organizations, Pharmaceutical Companies, or Academic Institutions for employment to add to my existing experience and create a stronger career platform in Regulatory Affairs. In addition, I plan to obtain a Masters in Regulatory Affairs.

Analyst

Dallas, TX

About Me

Industry:

Research

Occupation:

Analyst

Highlights:

As an IRB Consultant assisting a VA Researcher (Dr. Laura A. Petersen) and her staff in obtaining protocol approval for the Randomized Controlled Trial (RCT) of Financial Incentives to Translate ALLHAT into Practice study from the IRB and the Veterans Affairs Research & Development (R&D) committee for all nineteen (19) study sites. As Human Research Subject Protections Senior Analyst, playing a pivotal role in Baylor College of Medicine's AAHRP Accreditation by serving on quality improvement/accreditation teams and guiding and preparing my staff (Team of five IRB Analysts) for site visit with the Association for the Accreditation of Human Research Protections Program (AAHRPP). Obtaining my CIP. As Senior Health Planner, Co-authoring the Houston Health Department CDC Grant submission - Enhanced Comprehensive HIV Prevention Planning (ECHPP) and Implementation for Metropolitan Statistical Areas Most Affected by HIV/AIDS CDC for Funding Opportunity Announcement (FOA). As Senior Health Planner authored the MPact Houston Task Force Strategic Plan 2009 – 2011. For The Houston Area Comprehensive HIV Prevention and Care Services Plan for 2012 through 2014: As serves as one of two Health Planners and Support Staff that assisted with writing the Prevention [Bureau of HIV/STD/Viral Hepatitis Prevention & Houston HIV Prevention Community Planning Group (HHPCPG)] portion of Comprehensive Plan.
 

Education level:

Bachelor

Will Relocate:

Yes

Location:

Dallas, TX

Major Responsibilities

As Senior Health Planner: Develops evaluation techniques for HDHHS trainiig program. Assists with writing grants/funding announcements for submission to the Centers for Disease Control & Prevention (CDC). As Human Research Subject Protections Senior Analyst: Managed and lead the team of IRB Analysts supporting the six boards that comprise the BCM IRB. Served as IRB representative on sub-committees during audit inquiries on compliance issues as assessed by BCM Research Compliance Services. Provided education and regulatory guidance (OHRP, CFR, FDA, GCP, and HIPAA) to IRB members, IRB Analysts, PIs, and their staff.

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