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English
$
USD
I will provide monthly clinical research regulatory maintenance and support
About this Gig
Ongoing Clinical Research Regulatory Maintenance and Compliance Support
Already conducting clinical trials but need reliable regulatory expertise? I provide monthly retainer services for established research sites requiring consistent compliance support, document maintenance, and expert guidance.
What I Deliver Monthly:
- Regulatory document updates and maintenance
- Amendment preparation and IRB coordination
- Compliance monitoring and quality assurance
- Safety report management and tracking
- Protocol deviation documentation and reporting
- Expert consultation calls and email support
My Expertise: 7 years clinical research operations + 20 years healthcare experience. I understand the ongoing regulatory demands of active research sites and provide reliable, consistent support to maintain compliance.
Perfect For:
- Research sites needing ongoing regulatory backup
- Practices wanting expert oversight without full-time staff costs
- Sites requiring consistent amendment and compliance support
- Established sites seeking reliable regulatory partnership
Process: Monthly regulatory assessment, document updates, compliance monitoring
FAQ
How many hours of work are included in each package?
Basic includes 5 hours, Standard includes 10 hours, Premium includes 15 hours per month. Additional time available at $150/hour.
Can you handle urgent regulatory issues that arise?
Yes, I prioritize urgent compliance matters within your monthly hours. For true emergencies, additional hours are available at standard rates.
Do you work with all central IRBs?
Yes, I have experience with major central IRBs including WCG, Advarra, and others. I adapt to your specific IRB requirements.
How do we communicate throughout the month?
Primarily via email for routine matters, with scheduled consultation calls included in Standard and Premium packages. Phone support available for urgent issues.
Can I cancel or change my service level anytime?
Yes, you can modify or cancel with 30 days notice. I recommend discussing changes during our monthly check-ins.
