Regulatory Compliance Manager
4 weeks ago
We are seeking an experienced Regulatory Compliance Manager to join our team. In this role, you will be responsible for ensuring that all clinical research is conducted in compliance with regulatory requirements.
The ideal candidate will have 3-5 years of experience in clinical research regulatory affairs and the ability to work in a fast-paced environment.
- Experience working in a retina practice is preferred.
- A Bachelor's degree is preferred.
- Conduct study start-up activities
- Initial Application to IRB/Approval/Informed Consent Forms
- Complete 1572
- Financial disclosure Forms
- Prepare all documents for SIV/Activation
- Create and keep all SSDLs
- Maintain necessary documents for compliance
- Maintain IRB access
- Maintain compliance of regulatory documents
- Prepare for internal/sponsor/FDA audits as applicable
- Maintain GCP and other regulatory training requirements
- Maintain Regulatory training logs i.e.: Protocol, IB, Procedure Manuals, eCRF
- Guidelines, Lab Manuals, BCVA Manuals, ECG Manuals, IWRS etc.
- Complete all vendor start-up documents/activities as applicable
- Maintain Compliance with PI and SI training, initial and ongoing
- Manage regulatory documents for close-outs
- IRB close-outs
- Help facilitate research start-up/onboarding for ECOA Ophthalmologists, Glaucoma,
- Cornea Specialists as applicable
- Attend Investigator Meetings required for new trials
- Participate in Webex for SIV and other required meetings
- File documents as needed in regulatory binders
- Manage invoices from Broadway Elite and taxi invoicing reimbursement
- Maintain and prepare with Bookkeeper patient stipends
- Maintain log for patient checks/stipends
- Ensure all W-9 forms are signed by each research patient who receives a stipend
- Other duties as assigned
$90,000 - $110,000 per year, depending on experience.
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