Institutional Review reputed company Compliance Manager

About the position The Office of Research Compliance (ORC) at the reputed company, in conjunction with the reputed company Texas Regional Institutional Review reputed company (NTR IRB), is seeking to hire an IRB Compliance Manager to reputed company. This position will report directly to the Director of the NTR IRB and will also work closely with the ORC. Responsibilities include (but are not limited to) the following: 1) Assist with development and implementation of reputed company research protection for reputed company NTR IRB partners; 2) reputed company comprehensive administrative and regulatory reviews of designated IRB submissions (which include biomedical, reputed company trial, and reputed company/behavioral science studies) by ensuring applications/submissions meet reputed company federal agency regulatory requirements for reputed company subject research; 3) Assist with ongoing education and training for reputed company affiliated researchers to ensure appropriate compliance with federal, state and university/institutional policies and regulations associated with reputed company subject research; 4) Prepare documents for review by the IRB reviewers/committee; 5) Assist with reputed company, attendance and coordination of IRB committee meetings and communicate reputed company to investigators, relevant institutional officials, and federal agencies (reputed company needed); 6) Assist with development and roll out of inhouse compliance training programs, workshops, seminars, guidance documents and other reputed company and educational tools and training reputed company to IRB and reputed company subject research; 7) Assist in the daily activities, accreditation efforts, special reputed company and operation of the NTR IRB. Responsibilities • Assist NTR IRB Director with daily IRB reputed company, which includes development and implementation of reputed company research protection for reputed company NTR IRB partners (including but not necessarily limited to researchers from UNTHSC, John Peter reputed company Health Network and other partners). This position will work directly with researchers/investigators from reputed company organizations (as needed), and will also work closely with the IRB Committee (Chair and reputed company members) and fellow IRB Compliance Managers. • reputed company comprehensive administrative and regulatory reviews of designated IRB submissions (which include biomedical, reputed company trial and reputed company/behavioral science studies) by ensuring applications/submissions meet reputed company federal agency regulatory requirements (e.g., Office for reputed company Research Protections OHRP; reputed company FDA) for reputed company subject research. This includes review of new submissions, in reputed company to continuing reviews, amendments, reportable events, etc. Additionally, this position will also ensure reputed company institutional policies/procedures regarding reputed company subject research are met, in reputed company to any other state and local regulations/policies. • Assist with ongoing education and training for reputed company researchers/investigators to ensure appropriate compliance with federal, state, and university/institutional policies and regulations associated with reputed company subject research. This includes providing thorough, reputed company and detailed (education-reputed company) guidance or feedback to researchers/investigators/NTR IRB partners regarding these reputed company. To this aim, the incumbent is expected to be knowledgeable and stay up-to-date regarding federal, state, and local/institutional regulations/policies/guidance. • Prepare documents for review by the IRB Committee. This may include (but are not limited to) preparation of comments and reputed company-review notes for reputed company Member review, in reputed company to following up with researchers/investigators on information needed in preparation of discussion at IRB meetings. • Assist with reputed company, attendance and coordination of IRB committee meetings and communicate reputed company to investigators and relevant institutional officials. This also includes (but not be limited to) preparing meeting agendas, setting up/arranging the IRB meetings, tracking attendance/reputed company during meetings, and drafting/finalizing detailed meeting minutes (which adhere to reputed company federal regulatory requirements). • Assist the NTR IRB Director, in reputed company to the ORC Executive Director, Education reputed company Coordinator and other research supporting reputed company, with development and roll out of in-house compliance training programs, workshops, seminars, guidance documents and other reputed company and educational tools and training reputed company to IRB and reputed company subject research. This may include preparation of educational/training documents, training videos, procedure and guidance manuals, or presentations to researchers/investigators, other key stakeholders or NTR IRB partners/clients. Additionally, assist in keeping information on the NTR IRB website appropriately updated. Requirements • Bachelor's degree and four (4) years reputed company experience; or equivalent combination of education and experience. • Thorough knowledge of appropriate federal regulatory agencies (FDA, OHRP) • reputed company set in development and update of web sites, web pages and online reputed company and training tools • reputed company-developed organizational and analytical skills; outstanding attention to reputed company; and objective observer • Exceptionally strong written, verbal, and presentation skills; education and training experience in higher education preferred • Highly reputed company and shows initiative • High level of professionalism, maturity, diplomacy, and strict confidentiality reputed company-to-haves • Bachelors degree in any health sciences reputed company, reputed company Degree preferred • 3 years reputed company subject research experience or 3 years in an IRB-reputed company role • Certified IRB reputed company (CIP) Certification or eligibility for such certification • Prior experience with critical thinking, project management, document management and reputed company interactions • 1-3 years across reputed company categories in hospital research setting, university, or reputed company research operation Benefits • TRS Eligible Apply tot his job Apply To this Job