Clinical Research Coordinator 1 - Regulatory Fulltime Days
Inova HealthAbout the role
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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We are Inova, Northern Virginia’s leading nonprofit healthcare provider. Every day, our 24,000+ team members provide world-class healthcare to the communities we serve. Our people are the reason we're a national leader in healthcare safety, quality and patient experience. And from best-in-class facilities to professional development opportunities, we support them at every step. At Inova, we're constantly striving to be ever better — to shape a more compassionate future for healthcare.
Inova Health System is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, pregnancy (including childbirth, pregnancy-related conditions and lactation), race, religion, sex, sexual orientation, veteran status, genetic information, or any other characteristics protected by law.
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