Program Coordinator
Bethesda, MD 
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Posted 6 days ago
Job Description

Join the HJF Team!

HJF is seeking a Program Coordinator to support our Vaccine Development and Production (VDP) Team for the Military HIV Research Program (MHRP) located at Rockledge Drive in Bethesda, MD and reports to VDP Quality Affairs Management. HJF provides scientific, technical and programmatic support services to VDP/MHRP.

The incumbent will be responsible for providing administrative project oversight in order to maximize the effective use of project resources. Specific areas include: budget and accounting, space management, contracts, and purchasing. Works on abstract problems and identifies and evaluates fundamental problems for major functional areas through assessment of intangible variables. Coordinates the regulatory process for pre-clinical evaluation of HIV vaccine products leading to Phase I/II- IND FDA submission within the US Military HIV Research Program utilizing regulatory expertise in MHRP or accessed through consultants and collaborations with sponsors.

Responsibilities:

  1. Provides general management oversight for individual projects within Vaccine Development and Production section of the clinical research directorate with an emphasis on GMP/GLP projects but also clinical research activities.
  2. Facilitates information flow between program members, scientific directors, and the Foundation.
  3. Coordinates the decision-making process between department and program participants.
  4. Projects, executes, and assist in management of the budget for the vaccine production and development programs.
  5. Analyzes costs and pricing data by contract centers to verify and substantiate direct and indirect costs.
  6. Prepares requests for contract actions and proposals. Assures full compliance with all contract requirements, schedules, and provisions.
  7. Coordinates with HJF Contracting and Legal/Agreement teams to initiate and maintain agreements and contracts (i.e., MTA, CDA, CRADA, etc.) with outside entities for VDP and projects in support of NHP studies.
  8. Review and approve Technical Agreements.
  9. Through continuous communication with consultants and collaborators, determines submission requirements, plans submission process, engages with various contract organizations to facilitate the cGLP toxicology studies as well as appropriate analytical and biological tests to support cGMP release of new vaccines.
  10. Assist in the development, review, and approval of documents (IBs, Products Specs, Pre-IND, IND) governed by in-house and external Quality Systems.
  11. Complete other duties as assigned.

Required Knowledge, Skills and Abilities: Knowledge of organizational objectives, the federal budget process, office automation; ability to work independently; ability to use sound judgment in solving problems; ability to coordinate many complex systems and programs simultaneously; excellent written and oral communication and interpersonal skills; solid understanding of cGMPs, FDA guidelines, and experience working with the FDA and other regulatory groups; individuals should be flexible and able to adapt to new projects and scientific and regulatory goals of the program.

Minimum Education: Bachelor’s degree from an accredited college/university in a scientific discipline required (chemistry, biology, biochemistry, immunology, virology etc.). Foreign degrees must be evaluated for U.S. equivalency.

Minimum Experience/Training: 0 – 2 years of related experience in scientific project or program coordination and regulatory affairs experience; Experience working in or coordinating with the the U.S. Army Acquisitions environment; Work in vaccine/biologics field and previous experience working with the FDA is desirable. Experience writing technical and regulated documents a plus.

Work Environment: Office Settings; availability to address urgent issues on weekends and evenings is expected.

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.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
0 to 2 years
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