Regulatory and Start Up Specialist
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Job Description
Regulatory and Start Up Specialist in clinical research managing site activation and ensuring compliance with regulations. Collaborating across teams and preparing essential regulatory documents.
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, Site Activation Manager (SAM), Project Management team, and other departments
- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines
- Perform start up and site activation activities according to applicable regulations, SOPs and work instructions
- Distribute completed documents to sites and internal project team members
- Prepare site regulatory documents, reviewing for completeness and accuracy
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information
- Review and provide feedback to management on site performance metrics
- Review, establish and agree on project planning and project timelines
- Ensure monitoring measures are in place and implement contingency plan as needed
- Inform team members of completion of regulatory and contractual documents for individual sites
- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning
- Perform quality control of documents provided by sites.
Requirements:
- Bachelor’s Degree in life sciences or a related field
- 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards
- Understanding of regulated clinical trial environment and knowledge of drug development process
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Benefits:
- Employee Referral Payment
- Standard Referral Bonus Plan
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