ASRC Federal
DoD Health Research Protection Analyst
ASRC Federal, Falls Church, Virginia, United States, 22042
Overview
DoD Health Research Protection Analyst role at ASRC Federal. Join our team to contribute to mission-critical programs in health research protection and compliance. Responsibilities
Provide program analysis and support for the Defense Health Agency (DHA) Component Office for Human Research Protections (COHRP) and Component Office for Research Integrity and Misconduct (CORIM). These Components oversee HRPPs at military medical and dental treatment facilities. Provide subject matter expertise in implementation of and ensuring compliance with 32 CFR part 219, 45 CFR part 46 Subparts A-E, 21 CFR parts 50 and 56, DoD Instructions 3216.01 and 3216.02, 10 U.S.C. part 980, and other applicable Federal, State, and local regulations. Provide program analysis and support for the HRPP Assurance granting and oversight process, including reviewing Assurance requests, HRPP SOPs, and IRB policies and procedures. Conduct audits of DoD institutions requesting new or renewed HRPP Assurance. Support the development of research policy, organize working groups, and draft and coordinate DHA Procedural and Administrative Instructions (DHA-PI and DHA-AI) that implement the Human Research Protections Program across the Military Health System. Perform program analysis and support for QA and research integrity initiatives of the ORP. Support conducting formal and informal reviews of actions taken by research review systems, including IRBs, Human Research Protection Officials, and Exemption Determination Officials (EDOs); review protocol applications, modifications, and status report submissions for government approval or concurrence. Coordinate and facilitate meetings by providing attendees with materials, arranging conferencing, attending meetings, and preparing summaries of proceedings. Provide support in the development and maintenance of training programs for researchers, reviewers, and institutional officials for human subjects and animal research. Provide support to the government with investigating and resolving unanticipated problems and allegations of noncompliance or research misconduct. Develop and distribute newsletters and routine information updates for ORP stakeholder communities. Provide support for the Electronic Institutional Review Board (EIRB), including coordinating ESC and subcommittee meetings, serving as the primary point of contact with the EIRB program management office, maintaining the EIRB change request backlog, providing training in EIRB use, and drafting policy and guidance for EIRB use. Requirements
Minimum Bachelor’s degree and five (5) years related experience. Experience in a human/animal research protection environment, preferably in a compliance, oversight, regulatory, research integrity, or advisory role. Must be a US Citizen with ability to obtain a Secret level clearance. Ability to successfully pass a DHA background investigation. We invest in the lives of our employees, both in and out of the workplace, by providing competitive pay and benefits packages. Benefits offered may include health care, dental, vision, life insurance; 401(k); education assistance; paid time off including PTO, holidays, and any other paid leave required by law. EEO Statement: ASRC Federal and its Subsidiaries are Equal Opportunity employers. All qualified applicants will receive consideration for employment without regard to race, gender, color, age, sexual orientation, gender identification, national origin, religion, marital status, ancestry, citizenship, disability, protected veteran status, or any other factor prohibited by applicable law.
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DoD Health Research Protection Analyst role at ASRC Federal. Join our team to contribute to mission-critical programs in health research protection and compliance. Responsibilities
Provide program analysis and support for the Defense Health Agency (DHA) Component Office for Human Research Protections (COHRP) and Component Office for Research Integrity and Misconduct (CORIM). These Components oversee HRPPs at military medical and dental treatment facilities. Provide subject matter expertise in implementation of and ensuring compliance with 32 CFR part 219, 45 CFR part 46 Subparts A-E, 21 CFR parts 50 and 56, DoD Instructions 3216.01 and 3216.02, 10 U.S.C. part 980, and other applicable Federal, State, and local regulations. Provide program analysis and support for the HRPP Assurance granting and oversight process, including reviewing Assurance requests, HRPP SOPs, and IRB policies and procedures. Conduct audits of DoD institutions requesting new or renewed HRPP Assurance. Support the development of research policy, organize working groups, and draft and coordinate DHA Procedural and Administrative Instructions (DHA-PI and DHA-AI) that implement the Human Research Protections Program across the Military Health System. Perform program analysis and support for QA and research integrity initiatives of the ORP. Support conducting formal and informal reviews of actions taken by research review systems, including IRBs, Human Research Protection Officials, and Exemption Determination Officials (EDOs); review protocol applications, modifications, and status report submissions for government approval or concurrence. Coordinate and facilitate meetings by providing attendees with materials, arranging conferencing, attending meetings, and preparing summaries of proceedings. Provide support in the development and maintenance of training programs for researchers, reviewers, and institutional officials for human subjects and animal research. Provide support to the government with investigating and resolving unanticipated problems and allegations of noncompliance or research misconduct. Develop and distribute newsletters and routine information updates for ORP stakeholder communities. Provide support for the Electronic Institutional Review Board (EIRB), including coordinating ESC and subcommittee meetings, serving as the primary point of contact with the EIRB program management office, maintaining the EIRB change request backlog, providing training in EIRB use, and drafting policy and guidance for EIRB use. Requirements
Minimum Bachelor’s degree and five (5) years related experience. Experience in a human/animal research protection environment, preferably in a compliance, oversight, regulatory, research integrity, or advisory role. Must be a US Citizen with ability to obtain a Secret level clearance. Ability to successfully pass a DHA background investigation. We invest in the lives of our employees, both in and out of the workplace, by providing competitive pay and benefits packages. Benefits offered may include health care, dental, vision, life insurance; 401(k); education assistance; paid time off including PTO, holidays, and any other paid leave required by law. EEO Statement: ASRC Federal and its Subsidiaries are Equal Opportunity employers. All qualified applicants will receive consideration for employment without regard to race, gender, color, age, sexual orientation, gender identification, national origin, religion, marital status, ancestry, citizenship, disability, protected veteran status, or any other factor prohibited by applicable law.
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