Human Research Protection Program (HRPP)and Conflict of Interest (COI) Manager

Clearance Level
None
Category
Regulatory Affairs
Location
Lackland AFB, Texas

REQ#: RQ66671

Travel Required: None
Public Trust: NACLC (T3)
Requisition Type: Regular

GDIT is seeking a Human Research Protection Program (HRPP) and Conflict of Interest (COI) Manager in support of the 59th Medical Wing (59 MDW). The 59th Medical Wing Science and Technology (ST) office advises and conducts clinical and translational research on matters pertaining to the medical aspects of the Air Expeditionary Force and the health of Air Force (AF) personnel and beneficiaries. In order to support the required research, ST offices conduct translational research in the areas of emergency medical care, combat casualty care, force health protection, restorative medicine, clinical and rehabilitative medicine and specialty centers.

Duties & Responsibilities:

•    Assist with the development and implementation of 59 MDW COI policies, procedures, practices and training programs designed to promote compliant practices and mitigate risk.

•    Create, coordinate, and implement strategies to improve COI office productivity and 59 HRPP.

•    Maintain COI records, analyze data, and prepare reports for various regulatory bodies.

•    Promote awareness of 59 MDW Human Research Protection Program and Conflict of Interest policies and procedures to include Institutional and Investigator COI.

•    Provide comprehensive regulatory guidance to the 59 MDW research community.

•    Maintain  awareness  of  federal,  state,  and  local  developments  and  compliance  efforts
related  to research  and  develop  communication  tools  to  share  this  information  effectively  across  the  59  MDW research community.

•    Provide  coordination  and  administrative  support  for  Scientific  Ethics  Subcommittee  
(SES)  meetings; maintenance of records documenting the SES activities and conducting 
investigations of allegations of scientific misconduct and conflicts of interest that involve human subjects in research.

•    Develop and maintain COI management plan database and track compliance with management plans.

•    Lead special COI projects from concept to completion.

•    Responsible for 59 MDW Human Research Protection Program (HRPP) accreditation preparation and accreditation maintenance.

•    Coordinates and tracks conflict of interest training, and reports metrics to various 
committees, such as 59 MDW Scientific Advisory Committee, 59 MDW HRPP Steering Committee.

•    Committee member providing guidance pertaining to human research protection, ethical 
considerations and conflict of interest for 59 MDW Scientific Advisory Committee, Scientific Ethic Subcommittee and 59 MDW HRPP Steering Committee

•    Monitors  related  Human  Research  Protection  regulatory  updates  and  industry  best  
practices  and incorporates them in training and HRPP/COI policies and procedures

•    Monitors  the  efficiency  and  accuracy  of  conflict  of  interest  self-reporting  by  
biomedical  research investigators/research staff.

•    Serves  as  advisor  to  the  IRB  chair  and  IRB  members,  departments  and  
individuals/investigators conducting  or  supporting  human  subjects  research  on  matters  
pertaining  to  Human  Research Protection and financial COI

•    HRPP/COI Manager will work under the direction of the 59 MDW Chief Scientist and in 
collaboration with      compliance  officials  across  59  MDW  to  align  processes  to  ensure  
consistency  across  all programs.

Knowledge/Skills/Abilities:

•       Knowledge   of   federal   policies   concerning   human   research   protection,   
including   application   of Common Rule; HIPAA; and other human research protection regulatory requirements.

•       Knowledge of AAHRPP accreditation standards and accreditation process.

•       Demonstrated ability to develop and facilitate adult education curricula.

•       Strong interpersonal skills and ability to work effectively with diverse constituencies.

•       Propensity to working in a complex scientific environment with multi-dimensional points of view.
•       Detail oriented, self-starter, eager to do hands on work to get the job done correctly and 
on time.
•       Ability to approach problems and decisions analytically; Critical thinking and active 
listening skills.
•       Outstanding  written/verbal  communication  and  computer  skills  coupled  with  an  open,  honest  and respectful communication style.
•       Possess verbal communication skills to present briefings, other updates/presentations to audiences with varying compliance background.
•       Proficiency with Microsoft Office Suite and Acrobat Adobe.
•       Experience with HRPP administration, regulatory and HRPP accreditation.
•       Ability to gather data, compile information, and prepare reports.
•       Ability to train investigators from any number of research disciplines in principles of 
Human Research Subjects Protection.
•       Working knowledge of ethical principles related to participation of humans in research 
(essential).
•       Ability to maintain confidentiality of information.
•       Excellent organizational skills; professional conduct and business like manner; meticulous  attention to detail; committed to helping build and sustain the teamwork.

Minimum Qualifications and Experience:
•       Bachelor's  degree  in  sciences,  nursing,  social  sciences  or  relatable  healthcare  
business  required; Master's degree in Clinical Research or related field preferred.
•       Must  possess  thorough,  working  knowledge  of  Human  Research  Subject  Protection,
research administration  or  compliance,  conducting  human  subject  research  and/or  clinical  trials  coordination required.
•       Intermediate+  experience  with  Microsoft  Office  applications  including:  Word,  Excel, 
 PowerPoint, Outlook, SharePoint.
•       Experience in use of computerized information systems related to Human Subjects Research required (i.e. eIRB or related software).
•       Successful  completion  and  maintenance  of  Human  Subjects  training  /  training  in  
human  subjects' research protection, bioethics, and HIPAA.
•       Certified  Clinical  Research  Coordinator  (CCRC),  Certified  Clinical  Research  
Professional,  Certified IRB Professional (CIP) or Certified IRB Manager (CIM) strongly preferred.
 

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.