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Clinical Research Regulatory Coord 1-Full Time

1 month ago

Fairfax, United States Inova Health System Full time

Inova Employee Benefits and Perks:

  • Health, Vision, and Dental Coverage
  • Life Insurance, Short/Long Term Disability
  • NEW 4 weeks PAID PARENTAL LEAVE
  • Retirement: Inova matches dollar for dollar the first 5% of your eligible pay that you contribute to the plan
  • Competitive salary: Pay based experience.
  • Amazing Paid Time Off: Accrue PTO hours on your very first day of work.
  • Supplemental Plans: Including Auto/Home Insurance discounts, Pet Insurance, Identity Theft Protection
  • Additional Benefits: Educational Assistance of up to $5,250/year, Student Loan Refinancing, Adoption Assistance, Child Care Centers, Scholarship Program, Free Parking, Exclusive savings opportunities to in-store events, theme parks, discounts, movie tickets and local offerings and so much more

Requirements for consideration:

Minimum Education:

  • Associate degree (or relevant experience in lieu of degree)

Years of Experience:

  • No experience required.
  • Research, Regulatory or Phase 1 experience preferred.

Certification:

  • N/A

Job Responsibilities

  • Supports the study process and is responsible for collecting and providing sponsors with regulatory documents.
  • Responsible for clinical studies through the regulatory portion of the trial; maintaining the regulatory integrity of assigned studies from approval to closure.
  • Explains basic elements of subject safety including the reasoning behind the required use of an Institutional Review Board Independent Ethics Committee, study activity documentation, and event reporting requirements.
  • Demonstrates subject protection under direct supervision.
  • Explains the investigational products development process and identify key regulations to control these processes.
  • Coordinates the preparation and submission of new studies to appropriate committees, including the Office of Research at Inova, DSMC, PRMC, IRBs, and other committees as necessary, including drafting and/or editing of informed consent documents.
  • Coordinates the start-up activities of multiple studies including IRB, contract, and budget submissions.
  • Other duties as assigned.

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