Regulatory Affairs Assistant

Updated: November 8, 2019
Job ID: 215400
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

Join the HJF Team!

HJF is seeking a Regulatory Affairs Assistant to support the Regulatory Affairs Department located at HJF Home Office in Bethesda, MD. The incumbent provides administrative support to the Director, Office of Regulatory Affairs and Research Compliance and to the department as assigned.   

Responsibilities: 

  1. Receives incoming telephone calls and visitors for the department; receives, screens, and distributes incoming mail. 
  2. Complete CITI training reports and quality assurance for the training program assigned by the department to all HJF employees. Prepare daily reports from CITI and submit to HQ raining Department for input into the Learning Center. 
  3. Makes necessary arrangements for conferences and meetings for the department.
  4. Collects and prepares materials for meeting and training sessions.  
  5. Updates/maintains Directors calendar and the department calendar daily.  
  6. Performs typing assignments and proofreads all work. Correspondence prepared is proofread adequately to ensure a minimum of grammatical or typographical errors and formatted errors.
  7. Handles detailed matters that are confidential and critical.  
  8. Orders and maintains department office supplies; processes invoices in Oracle for the department.  
  9. Prepares weekly and monthly reports from the department databases for QA. 
  10. Prepares and maintains electronic CV/training files for research personnel on protocols that come through the department and updates the department database.
  11. Maintains electronic version of agreements used in the department (BAA, IAIRs, IAA, DSA, DSAA, SSV, etc.), along with up to date spreadsheets of the agreements.
  12. Maintain publication approval tracking database for publications affiliated with HJF or HJF employees.
  13. Files paper and electronic documentation in an appropriate manner.  
  14. Operates automated office equipment as needed.
  15. Coordinates office activities and assists with various internal projects/work overflows.
  16. Copies documents as required; obtains signatures from other departments as required; 
  17. Performs other duties as assigned.

Required Knowledge, Skills, and Abilities: Excellent telephone manner and customer services skills, and effectively communicate with a diverse group of people.  Excellent word processing, proofreading, computer, interpersonal, communication and grammatical skills; specific experience required in Microsoft Word, Excel, PowerPoint and Filemaker.  Ability to anticipate needs, take initiative and follow through; excellent organizational skills for filing and office organizing.  Ability to quickly learn and absorb procedures and to establish goals and agendas. 

Minimum Education/Training Requirements: Associate degree preferred.

Minimum Experience:  0 - 2 years office experience.

Physical Capabilities: Must be able to work on computer for long periods of time; must be able to lift and carry large boxes up to 25 lbs.

Work Environment: Office environment.

Background: U.S. Citizenship required; eligibility to obtain and hold a Secret Security 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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