Regulatory Affairs Coordinator

This job posting is no longer active

Updated: January 27, 2018
Job ID: 213518
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

Come Work at HJF!

HJF is seeking a Regulatory Affairs Coordinator to support the Regulatory Affairs Department located at the Corporate Headquarters in Bethesda, Maryland. Responsible for assisting the Manager and the Regulatory Affairs Specialist in oversight of HJF’s Human Use and Animal Use Programs.

Responsibilities:

  1. Assist with the coordination and obtaining of necessary and required documents needed for review of grants, contracts, clinical trials and other research activities to ensure compliance with relevant federal and local regulations and policies of research involving human subjects, laboratory animals, and utilization of recombinant DNA.
  2. Assists with maintaining a regulatory database to include data entry, queries and reports. Suggests ideas for continued improvement to the Regulatory Affairs Database. Works with the Manager and Director to implement the changes.
  3. Maintains effective liaison with Principal Investigators, Program Administrators, Institutional Review Boards (IRBs), Laboratory Animal Review Committees (LARCs), and Institutional Biologics Committee (IBCs) where Foundation research is being conducted.
  4. Assists the Manager with compliance, regulatory, special projects and preparing for research training activities for principal investigators and research personnel.
  5. Assists with training the Regulatory Affairs Assistants.
  6. Monitors publications and website information from federal regulatory agencies to gain current information concerning changes in regulatory policy.
  7. Completes other projects as needed.

Required Knowledge, Skills, and Abilities: Knowledge of federal and local regulations and policies pertinent to research involving human subject, laboratory animals and recombinant DNA; excellent communication, interpersonal and organizational skills; ability to utilize computer applications packages, such as eIRB, Filemaker, MS Word, Excel, PowerPoint, 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, animal use in research and HIPAA.

Minimum Experience: 3-4 years-related experience in the area of human use, clinical research or laboratory animal research. 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.

Required Licenses, Certification or Registration: Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA); or other certification required. Must be a US citizen and be able to obtain a CAC card.

Work Environment: Office environment. Local travel can be anticipated about 10% of the time.

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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