
Regulatory and Site Activation Expert
1 day ago
Site Activation Specialist Role
This role is responsible for performing site activation activities at a country level, ensuring compliance with local and international regulations, standard operating procedures (SOPs), project requirements, and contractual guidelines. The ideal candidate will possess excellent organizational skills and be proficient in the local language.
Key Responsibilities
- Act as SPOC for investigative sites, SAM, and other departments as necessary.
- Prepare site regulatory documents and perform start-up activities.
- Ensure compliance with SOPs, WIs, and quality standards.
- Maintain accurate internal systems and tracking tools.
- Collaborate with the Project Management team to establish project planning and timelines.
- Implement contingency plans as needed.
- Inform team members of completed regulatory documents for individual sites.
- Track and follow up progress, approval, and execution of documents in line with project timelines.
- Offer local expertise during project planning and implementation.
Requirements
At least 1 year of clinical research experience is required.
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