Pursuant to a customer requirement, this position is contingent on providing proof of COVID-19 vaccination or submitting to regular COVID-19 testing at your own expense. Must be able to meet customer facility COVID requirements.
What You’ll Be Doing:
Provide real-time oversight of USAMRMC-supported research protocols through timely documented reviews of protocol lifecycle actions to assure ongoing compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRMC human subjects protection regulatory requirements.
Provide regulatory-based written review of protocol life cycle actions using standardized checklists.
Delineate deficiencies and areas of noncompliance and makes recommendations to the HRPO federal AAs regarding regulatory and ethical issues in HRPO post-approval submissions.
Provide a comprehensive review and evaluation of protocol amendments/addenda, continuing review reports, reports of unanticipated problems and serious adverse event, reports of serious or continuing noncompliance, reports of research suspension/termination, protocol deviations, subject complaints, and final study reports and provide a professional quality written review, as required.
Provide accurate information, assistance, and documents to customers and HRPO federal personnel when requested with appropriate professionalism in a timely manner. This will require active management and updating the protocol files and the information management systems used to track information related to protocol review.
Support the HRPO federal personnel in the conduct of noncompliance investigations and compliance inspections of extramural protocols. Shall provide regulatory-based written review of HRPO reportable events. Support includes preparing, planning, conducting, and reporting on compliance inspections of research for which HRPO has oversight.
Assist in the preparation of the written report of each compliance inspection that includes, but is not limited to, written specific findings of the inspection and recommendations that would enable the institution to bring the research into compliance.
Provide support for staff assistance visits and HRPP assessments designed to monitor compliance with human subjects protection regulations and make recommendations for improvement. This includes assisting with planning, formulation of agenda and preparation of materials for use during the visit, to include any educational presentations.
Participate in interviews with investigators, study staff, IRB staff, institutional officials, and research participants, and conduct detailed policy and regulatory record reviews, complete staff assistance checklists, and assist with preparation of after-action reports.
Travel to sites, as needed, to support HRPO federal personnel to provide compliance oversight to USAMRMC-supported research studies.
Provide support for the HRPO transition from paper to electronic review processes, including implementation and training on electronic review processes.
Assist the Government to develop policies, procedures, guidelines, and other materials to ensure compliance with current regulations and to update investigators, research managers and administrators, and administrative staff on human subjects protection and regulatory compliance policies and procedures as they apply to research supported by the USAMRMC.
Assist in the development of local procedures and guidance for the HRPO and the USAMRMC in the area of human subjects’ protection.
Support the development and implementation of effective mechanisms to communicate and interpret these regulations, policies, and guidelines.
Assist in development and implementation of internal HRPO operating procedures and review guidelines as requested.
Foster regulatory compliance through education and training of investigators, research managers, administrators, and HRPO staff, and provide assistance to program offices and investigators with interpretation of human subjects protection and cadaver use requirements.
Acquire and retain knowledge of current Federal, DoD, DA, state, host nation, and USAMRMC regulatory requirements related to the protection of human subjects in research and cadaver use and apply knowledge of these regulations and general ethical principles during HRPO reviews of assigned projects.
Bachelor’s Degree in a scientific, or related discipline
2+ years of related human subjects protection experience
Must possess a working knowledge of the Federal regulations governing the protection of human research subjects, including a firm foundation in the Common Rule and FDA regulations, to allow for effective and responsible management of a caseload of research protocols submitted for HQ USAMRMC review and oversight
Working knowledge of ethical principles related to participation of humans in research
Working knowledge of scientific research concepts and terminology to properly conduct detailed analyses of all research protocols submitted for IRB review
Following individual training and guidance, ability to become expert at applying DOD, Army and USAMRMC human subjects protection regulations, policies and guidelines
Proficiency with Microsoft Office Suite
Ability to become proficient in the use of an electronic document management system and Oracle based protocol information management system
US citizenship with the ability to pass a T1/ NACI security investigation
WHAT GDIT CAN OFFER YOU:
401K with company match
Internal mobility team dedicated to helping you own your career
Collaborative teams of highly motivated critical thinkers and innovators
Ability to make a real impact on the world around you
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We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.