Regulatory Affairs Specialist

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Updated: November 23, 2019
Job ID: 215083
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

Join the HJF Team!

HJF is seeking a Regulatory Affairs Specialist to support the Department of Pediatrics located at the Uniformed Services University (USU) in Bethesda, Maryland. HJF provides scientific, technical and programmatic support services to the Department of Pediatrics.

Regulatory Affairs Specialist responsibilities in the Department of Pediatrics (PED) at the Uniformed Services University (USU) includes the development, coordination and implementation of research protocols and management of related study activities by PED that are being conducted on-campus and/or at remote sites in coordination with national faculty and other collaborators. The incumbent will prepare protocol development work plans, and schedule and monitor study timelines during the protocol development and review process in coordination with the protocol chair /principal investigator, study team, study sponsor, and/or collaborative institution(s). The Regulatory Affairs Specialist will coordinate and participate in all aspects of protocol and related document development, from study concept to study closeout, in accordance with all regulatory requirements set forth by the US Department of Defense (DoD), US Food and Drug Administration (FDA), Institutional Review Boards/Ethics Committees (IRBs/ECs), Institutional Animal Care and Use Committee (IACUC), and Regulatory/Health Agencies (RA/HA) located at respective domestic and/or international participating sites. The incumbent will identify and resolve problems that may delay study initiation and progression, and facilitate protocol team communication for the duration of a study. In addition to protocol development, the Regulatory Affairs Specialist will manage site activation procedures if required, to include travel to international sites, to conduct training of site study personnel, review and approval of site readiness, develop protocol tools as necessary to assist participating sites in the safe and compliant conduct of clinical studies, and manage all protocol lifecycle actions in accordance with the above mentioned regulations. The incumbent will also perform other duties as assigned.

Responsibilities:

  1. Manage a portfolio of multiple protocols and projects through the development of work plans, study/project timelines and trackers in coordination with protocol teams to include the protocol chairs/PIs, study team, study Sponsors, and/or collaborative institutions.
  2. Collaborate with investigators and Sponsors to write and develop protocols and informed consent forms (ICFs) from concept to approval.
  3. Create other protocol-related documents including briefing slides, manual of operations, study-specific standard operating procedures, study tools and training materials among others.
  4. Manage version control of protocol and supporting documents throughout protocol submission and approval processes.
  5. Communicate with site teams, protocol teams, Sponsors, and collaborators in the US and at international sites in order to effectively manage the development of aforementioned protocol and study-related documents.
  6. Collaborate with investigators and/or clinical trial sponsors to develop scientific and regulatory documents for submission to the FDA (Investigational New Drug applications, annual reports, preclinical and clinical study reports, safety reports, and Investigator’s Brochures).
  7. Submit packets to USU IRB and other regulatory bodies, as required, and manage all submission related responses through approval, study start, and subsequent protocol lifecycle actions.
  8. Liaise with other PED technical and administration leads (lab, data, project management, finance, etc.) when developing protocol documents, project timelines and study trackers to ensure protocol activation requirements are in place.
  9. Implement site activation procedures to include planning the agenda, developing training materials in coordination with the PI, and training of site personnel (to include training on protocol-specific procedures, conducting mock runs, review of site capability and capacity, approval of site readiness, and development of protocol tools—including MOPs, SSPs, checklists, clinic flow charts, etc.) to assist participating sites in the safe and compliant conduct of a clinical trial. Travel to sites to conduct training and site review, as required.
  10. After study approval and initiation, management of all subsequent protocol lifecycle actions (amendments, continuing reviews, safety reporting, deviation reporting, etc.) until study closure.
  11. Work with PIs and sites and contribute in root cause analyses when deviations and unanticipated events occur in order to ensure proper reporting to IRBs and the development of CAPA plans and any associated tools for quality implementation of study.
  12. Maintenance of up-to-date information in real-time of study progress in the main protocol database.
  13. Compile and provide various program level reports and updates on status and progress of various protocols and projects in portfolio.
  14. Compile and generate necessary information needed for funding applications (e.g., work closely with the chair and investigators to complete and submit the application).
  15. Electronic file maintenance of all study documents and maintenance of version control of protocol documents. This includes Investigator CVs and required training records.
  16. Development and review of PED regulatory affairs Standard Operating Procedures, policies, guidance documents, tools and templates.
  17. Plan, coordinate and document various required meetings and conference calls to include protocol-specific, site, and other regulatory related meetings/calls. 
  18. Other duties as assigned.

Required Knowledge, Skills, and Abilities: Ability to compile, edit and write protocol documents and progress reports in a clear and concise manner utilizing scientific, medical, and technical writing skills. A writing sample will be required. Ability to work in a fast-paced research environment, and to plan and manage multiple priorities on different timelines. High level of initiative and ability to work with minimum supervision. Ability to quickly and effectively resolve complex issues. Flexibility to handle a variety of tasks and shift priorities as necessary. Excellent organization, time and project management skills with strong communication and interpersonal skills. Ability to effectively interact with external collaborators. Ability to work as an effective team member in a virtual environment. Knowledge of PCs and Macs. Basic knowledge of human anatomy, physiology, and related biological fields is highly desirable.

Minimum Education/Training Requirements: Bachelor’s degree required. 

Minimum Experience: 2 - 4 years of experience conducting or managing research.

Physical Capabilities:  Long periods of standing and sitting

Work Environment: Office environment. Local travel can be anticipated about 10-15% of the time. Infrequent international travel may be required.

Background: Eligibility to obtain a Common Access Card (CAC); eligibility to obtain and hold a 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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