Regulatory Affairs Assistant (Infectious Disease Clinical Research Program)

Updated: November 8, 2019
Job ID: 215405
Status: Full-Time
Regular/Temporary: Regular
Location: Portsmouth, VA, United States

Join the HJF Team!

HJF is recruiting for a Regulatory Affairs Assistant to support the Infectious Disease Clinical Research Program (IDCRP) at Naval Medical Center Portsmouth (NMCP), Portsmouth, VA. Responsible for assisting the management of the Regulatory Affairs Department in oversight of the Foundation’s Human Use Programs. US Citizenship is required for this position.

Responsibilities:

  1. Maintains effective relationship with Principal Investigators, Program Administrators, and Institutional Review Boards (IRBs) regulatory personnel, and others to ensure the continued scientific operational functioning of the organization at Department of Defense (DoD) Medical Treatment Facility (MTF) sites where IDCRP research is being conducted.
  2. Completes site protocol templates, memos, and other documents related to regulatory submissions and continuing reviews. Ensures site-specific IRB submissions, reports and continuing reviews are submitted prior to their respective deadlines.
  3. Reviews site study team’s determinations and documentation of protocol deviations, violations, and safety-related events (AEs, SAEs, etc.) and reports accordingly. Responsible for submitting events to the USUHS IRB, local IRB, and study Safety Monitoring group (as applicable).
  4. Maintains and distributes protocols and study documents. Maintains regulatory binders for all studies at the site and ensures local documents are posted to the IDCRP intranet. This includes updated CV’s, SOE’s, COI’s, Researcher Responsibility forms, required trainings for local study personnel, and site personnel list.
  5. Creates and maintains site SOPs and other regulatory operational documents.
  6. Prepares research training activities for principal investigators and research personnel. Tracks research training activity and ensure that the regulatory database and the regulatory binders are current at all times.
  7. Serves as local subject matter expert on electronic IRB system for both USUHS IRB and local IRB. Ensures local staff have accounts and are trained on system.
  8. In coordination with the Research Investigators, Site Manager, Clinical Research Manager, or designee, assists with study specific Quality Management reviews.
  9. Provides human subject monitoring support for the program. Coordinates and provides support for auditing, institutional monitoring, and inspection by authorized regulatory bodies.
  10. Maintains contacts information relevant to IDCRP operation, publications, presentations, abstracts, and other works. Manages submissions of authored works to internal and external reviewing authorities (local command, USUHS, journals, etc.).
  11. Monitors publications and website information from federal regulatory agencies to gain current information concerning changes in regulatory policy.
  12. Provides support to IDCRP network regulatory efforts through participation in special projects and regulatory working groups.
  13. May provide editorial reviews for research staff, administrative support such as typing, copying, proof reading, filing and archiving study related documents.
  14. Other duties as required.

Required Knowledge, Skills, and Abilities: Knowledge of federal and local regulations and policies pertinent to research involving human subjects is preferred; excellent communication, interpersonal and organizational skills; ability to utilize computer applications packages, such as MS Word, Excel, Powerpoint, Access, Adobe Acrobat, Smartsheet, eIRB, and E-mail.

Minimum Education/Training Requirements:  Bachelor’s degree in related field.  Must have completed training in human subjects protection in research.

Minimum Experience:  0 – 2 years experience; experience in a medical or scientific environment is preferred.

Physical Capabilities: Must be able to utilize computer for lengthy periods of time; perform routine filing; standing for lengthy periods of time utilizing Xerox machine for copying documents; must be able to travel to local sites occasionally.

Work Environment: Office environment.  Domestic travel may be necessary for training or in support of protocols and can be anticipated about 5% of the time.

Background: US Citizenship required. Ability to obtain and maintain Secret Clearance.

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check. 

HJF is an equal opportunity and 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 protected veteran status.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

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