Regulatory Specialist (Part-Time)
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Job Location:
Hourly Salary:
Experience Required:
Posted on:
21 hours ago
Vacancies:
1 Vacancy
Job Summary
Requirements
Required Skills:
Key Responsibilities - Prepare submit and track regulatory documents for IRB/IEC submissions amendments continuing reviews and study closeouts - Maintain regulatory binders essential documents and version control in accordance with ICHGCP FDA and site SOPs - Support study startup activities including feasibility documentation delegation logs and training records - Communicate with sponsors CROs and IRBs to ensure timely responses and document updates - Assist with audit readiness and regulatory inspections by maintaining accurate complete and compliant documentation - Coordinate with clinical and administrative teams to ensure regulatory timelines are met - Maintain compliance with HIPAA GCP and institutional policies
Required Education:
Qualifications- 2 years of regulatory experience in a clinical research setting (required)- Strong understanding of FDA ICHGCP and IRB regulatory requirements- Experience preparing and submitting regulatory packets and essential documents- Excellent organizational skills and attention to detail- Strong written and verbal communication abilities- Proficiency with Microsoft Office and common clinical research platforms (CTMS eReg eTMF preferred)- Ability to work independently and mana
Company Industry
Internet Service Providers / Retail Appliances / Electrical and Electronic Equipment
Key Skills
- Bidding
- Apps
- Benefits
- Corporate Recruitment
- Android Development
