Senior Human Subjects Protection Scientist/On-site Manager

Falls Church, VA
Jan 12, 2017
Mar 24, 2017
Full Time
Support is requested to provide a senior HSPS at Defense Health Headquarters (DHHQ) in Falls Church, VA. The Senior HSPS will serve as a research regulatory oversight subject matter expert (supporting the Research Regulatory Oversight Office (R2O2) within the Office of the Deputy Assistant Secretary of Defense for Health Readiness Policy and Oversight (HPR&O). The Senior HSPS will also serve as the on-site Program Manager.


Specific tasks include:


1) Provide comprehensive, timely, professional quality and fully documented reviews of research supported by the components of the USD P&R, including review and determinations for DoD intramural research and Human Research Protection Official Review for extramural research.


2) Assure compliance with all applicable Federal, DoD, state, host nation, and human subjects protection regulatory requirements and to delineate deficiencies and areas of noncompliance.  


3) Provide regulatory-based written reviews of protocols and life cycle actions (amendments/addenda, continuing review reports, reports of unanticipated problems and serious adverse events, reports of serious or continuing noncompliance, reports of research suspension/termination, protocol deviations, subject complaints, and final study reports) using standardized checklists.


4) Support the government in conducting reviews of assurance requests, including reviews of standard operating procedures (SOPs) and Institutional Review Board (IRB) records.


5) Formulate and recommend potential solutions to complex problems that would help bring protocols in compliance with the various laws, regulations, policies, procedures, and guidelines governing human subjects research, including regulatory coordination (work with other regulatory offices to coordinate human subjects protection reviews) as required.


6) Participate in interviews with investigators, study staff, IRB staff, and institutional officials and conduct detailed policy and regulatory record reviews and assist with preparation of after-action reports. 


7) Support the government in the preparation and staffing of the assurance assessment correspondence and preparing the report findings. 


8) Provide support for the conduct of site visits to customer institutions to monitor compliance with approved protocols from institutions that fall under OUSD P&R oversight and assist government with investigating and resolving unanticipated problems and allegations of noncompliance.


9) Support includes preparing, planning, conducting, and reporting on compliance inspections of research for which the OUSD P&R has oversight. 


10) Assist in the preparation of the written report of each compliance inspection that includes written specific findings of the inspection. 


11) Actively manage and update organizational documentation and information management systems used to track information related to protocol review and assurance oversight, i.e. maintain documents according to document management plan and maintain and track effective dates of agreements and assurances under R2O2 oversight.


12) Assess the contractor work products for accuracy, timeliness, and adherence to R2O2 requirements, automated data information system entries and use of the shared computer drive. 


13) Develop and coordinate organizational communications (website, information updates, newsletters, routine correspondence).   


14) Support the government in the development and sustainment of SOPs for the R2O2 and work with components of the OUSD (P&R) to develop and maintain their forms and standard operating procedures.


15) Coordinate with the USD P&R network of reviewers to address process issues; assist with regulatory interpretation; provide training as needed in new requirements, tools, forms, etc.; and provide other support as needed.


16) Provide consultation to assist institutions that fall under OUSD P&R oversight to develop and update their human subjects protection policies, procedures, guidelines, templates, and review checklists to ensure regulatory compliance with current laws, regulations, and policies governing human subjects research.


17) Provide consultation to assist institutions under USD P&R oversight in electronic IRB system submission and use, including training and helpful hints for using the online system, tracking milestones and general system updates, providing research oversight guidance and information.


Management related tasks:


1) Manage a small caseload of protocols to ensure he/she remains current on process and can provide appropriate guidance to contract staff.


2) Provide on-site, day-to-day work supervision for the contract personnel employed at the R2O2, to include assigning work to R2O2 contractor personnel.


3) Maintain a positive work environment to facilitate staff success in their job performance.


4) Ensure that personnel are adequately oriented to their duties and to the standards and expectations of the R2O2 within the initial 3 months of employment (with accommodation for Common Access Card issuance delay).


5) Provide quality assurance oversight for contractor activities and ensure that deliverables meet all timeliness and quality standards.


6) Ensure that accurate regulatory and procedural guidance are provided in a timely and professional manner.


7) Ensure that all additional contractor duties are performed in a timely and professional manner. The contractor shall perform supervisory functions for contractor staff.  The contractor shall monitor quality of deliverables and workplace performance.


8) Provide expert human subjects protection advice to staff when requested.


9) Ensure continued and up-to-date HSPS professional competency through continuing education and participation in other professional activities.

Education Masters Degree in a scientific discipline.

Qualifications 8-10 years of related experience in scientific research, analysis and/or engineering.

 Experience in policy development, and site visit audits preferred. As a trusted systems integrator for more than 50 years, General Dynamics Information Technology provides information technology (IT), systems engineering, professional services and simulation and training to customers in the defense, federal civilian government, health, homeland security, intelligence, state and local government and commercial sectors.With approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services.GDIT is an Equal Opportunity/Affirmative Action Employer - Minorities/Females/Protected Veterans/Individuals with Disabilities.