Regulatory Operations Associate - Clinical Research

Location
Bethesda, MD
Posted
Jan 03, 2019
Required Education
Bachelors Degree
Position Type
Full time

Founded in 1979, Technical Resources International, Inc. (TRI) provides a unique range of support services in the areas of Communications, Health and Information Technology to both private industry and government agency clients.  TRI is currently seeking a Regulatory Operations Associate to join our Bethesda, MD team.

Responsibilities:

  • Prepare standard documentation supporting regulatory filings and distribution to stakeholders.
  • Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents.
  • Maintain effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate.
  • Draft, edit, and distribute various documents as needed based on templates and work instructions.
  • Develop and maintain work process tools to promote efficiency and productivity.  These may include templates, SOPs, work instructions, checklists, etc.
  • Track regulatory activity, maintain and update databases, and ensure that records are complete and current.
  • Provide other administrative regulatory support as needed.    

Requirements:

  • B.A./B.S. Degree with 0-2years  work experience preferred.
  • Must have excellent attention to detail; verbal and written communication skills.
  • Superior organizational skills and customer service abilities are required.
  • Experience publishing regulatory submissions using electronic submission software (such as Extedo) and proficiency in preparing documents that are compliant with electronic submission standards is preferred.
  • Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus.  
  • Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects. 
  • Familiarity with Good Clinical Practices and/or experience of working in an FDA-regulated environment is desirable.
  • General knowledge of the drug and vaccine development process or clinical trials is a plus.

Submit resume and salary requirements to:  Attn: JK, TRI, 6500 Rock Spring Drive, Suite 650, Bethesda, MD 20817, or fax to (301) 897-1702, or email to HR@tech-res.com.

Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.