Regulatory and Start Up Specialist
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Job Description
Regulatory and Start Up Specialist managing site activation tasks in compliance with regulations. Supporting project management teams and ensuring timely completion of startup activities in Spain.
Responsibilities:
- Perform tasks at a country level associated with Site Activation (SA) activities
- Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites
- Ensure adherence to standard operating procedures (SOPs) and project timelines
- Perform start up and site activation activities according to applicable regulations
- Prepare site regulatory documents, ensuring completeness and accuracy
- Review and provide feedback on site performance metrics
- Inform team members of regulatory and contractual document completions
Requirements:
- 1-year clinical research experience within submissions
- Equivalent combination of education, training and experience
- Spanish language fluency
Benefits:
- Health insurance
- Professional development opportunities
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