Program Regulatory Affairs Specialist (Infectious Disease Clinical Research Program)

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Updated: October 26, 2019
Job ID: 215223
Status: Full-Time
Regular/Temporary: Regular
Location: Rockville, MD, United States

Join the HJF Team!

HJF is seeking a Regulatory Affairs Specialist to support the Infectious Disease Clinical Research Program (IDCRP) and its Program Coordinating Center (PCC) team. The Regulatory Affairs Specialist is responsible for the coordination and management of regulatory affairs related to the development and implementation of clinical research on multi-drug resistant infections, HIV/AIDS, influenza, and other infectious diseases relevant to the military. HJF provides scientific, technical and programmatic support services to IDCRP.  

Job Responsibilities:

  1. Serves as the IDCRP’s Regulatory Affairs Specialist, responsible for coordinating and managing regulatory affairs in support of protocol execution, working under supervision of the Chief of Quality Management.  
  2. Serves as the Program’s liaison with the USU Institutional Review Board (IRB) by maintaining regular and frequent communications with IRB support staff to foster efficiency in IRB protocol submissions and review processes, assist IDCRP study teams with resolution of regulatory affairs related issues, and facilitate a means for the IRB support staff to communicate updates to protocol review actions and IRB processes.
  3. Conducts pre-IRB regulatory review of protocols in coordination with IDCRP study teams and Program sponsors or other monitors.
  4. Manages and leads monthly Regulatory Affairs teleconferences among the Program study teams and the USU IRB staff, working with the Chief of Quality Management to develop agenda.
  5.  In coordination with the Chief of Quality Management, manages the audit process for regulatory files, including regular review, maintenance, and updating of the Virtual Regulatory Affairs binder. The Regulatory Affairs Specialist is authorized by the Program to mandate that IDCRP staff, such as CRMs or other responsible study team members, implement corrective actions to address deficiencies identified in the Virtual Regulatory Affairs binder.
  6. Maintains up-to-date regulatory affairs information on the IDCRP intranet.
  7. Participates in the creation and maintenance of program-wide regulatory-specific SOPs and other regulatory-related operations documents.
  8. Participates in for-cause clinical study site visits to review human subjects protection compliance, adherence to IRB-approved protocols procedures, and data integrity. Provides training as part of Program Quality Management activities. Implements and enforces corrective actions as needed.
  9. Provides regulatory affairs training and mentorship to IDCRP study teams and regulatory affairs support personnel throughout the network, this may include remote training or  travel to meet with and train study teams located at the PCC and throughout the IDCRP clinical study site network as needed.
  10. Coordinates program-related activities of site Regulatory Affairs staff at Military Treatment Facilities (MTFs). Disseminates Program policy information and collects and consolidates local policy information from site staff.
  11. Ensures applicable IDCRP staff have eIRB accounts and are trained on the system.
  12. Performs tracking and maintenance of Institutional Agreements for IRB (IAIR) between sites.
  13. Validates Summary of Education Forms.
  14. Provides oversight for ClinicalTrials.gov to ensure Program protocols are maintained on the site accordingly.
  15. Provides support to the IDCRP network regulatory affairs efforts through the initiation and leadership of process improvements and working groups.
  16. Maintains one or more professional certifications: CIP, CCRP, or CCRC
  17. Other duties as assigned.

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

Minimum Education/Training Requirements: Bachelor's degree in a scientific discipline or a related field is desired. Must have completed training in human subjects protection in research. CIP (Certified IRB Professional) certification preferred and required within 1 year of hire.

Minimum Experience: 2-4 years related experience in the area of human subjects’ protections.

Physical Capabilities:  Long periods of sitting and standing; some bending, lifting, and walking.

Required Licenses, Certification or Registration:  Certified in basic cardiac life support required; certified as a Clinical Research Coordinator (CCRC), Clinical Research Professional (CCRP), and/or Clinical Research Associate (CCRA) preferred.  

Work Environment:  Office environment. Travel may be anticipated up to 10% of the time.

Background: Eligibility to obtain a Common Access Card (CAC) and Public Trust background.

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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