Regulatory Coordinator II - Hybrid Opportunity
Job Description :
Looking to hire an individual with strong regulatory and clinical research experience to act as a Regulatory Coordinator II to support an ongoing clinical trials.
Please note, as the position and study progress, additional job duties will likely be added that are not listed in this description.
A candidate must help the site and study wherever needed depending on the specific assignment.
Responsibilities :
- Conducts study start-up activities and prepares / maintains all regulatory documents
- Coordinates with the IRB and Sponsors, preparing submissions, answering questions
- Helps identify and recruit patients and assists with informed consent process
- Prepares documents and facility for external audits by the sponsor or various regulatory agencies
- Evaluates protocols with the PI
- Prepares study invoices and billing, and works with the PI to assist with grant preparation and reporting
- Performs a variety of other regulatory and coordinator duties as required
Required Qualifications :
- Experience as a Regulatory Coordinator or Clinical Research Coordinator, ideally from a hospital / academic setting
- Experience with electronic medical records (EMR)
- Experience with electronic data capture (EDC) systems
- Experience with IRB submissions and other regulatory duties
Additional Details :
Location : Fort Worth, TX
Duration : 9-month contract to hire
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