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Regulatory Compliance Specialist
hace 1 mes
We are seeking a highly skilled Regulatory Specialist 2, Fsp to join our team at Novasyte. As a key member of our site activation team, you will be responsible for ensuring compliance with local and international regulations, standard operating procedures (SOPs), project requirements, and contractual guidelines.
Key Responsibilities:
- Under general supervision, serve as the Single Point of Contact (SPoC) for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary, ensuring adherence to SOPs, Work Instructions (WIs), quality of designated deliverables, and project timelines.
- Perform start-up and site activation activities in accordance with applicable regulations, SOPs, and work instructions, distributing completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing them for completeness and accuracy.
- Evaluate the accuracy of internal systems, databases, and tracking tools regarding project-specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish, and agree on project planning and project timelines, ensuring monitoring measures are in place and implementing contingency plans as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Track and follow up on the progress, approval, and execution of documents, including regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, within project timelines.
- Provide local expertise to SAMs and project teams during initial and ongoing project timeline planning.
- Perform quality control of documents provided by sites.
- Maintain direct contact with sponsors on specific initiatives.
Requirements:
- Bachelor's Degree in Life Sciences.
- +3 years of clinical research experience within the regulatory area, including submissions, knowledge of ICFs, presentations to ethics committees, and COFEPRIS.
- Fluent English language skills, with written and oral communication proficiency.
About Us
Novasyte is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We strive to push the boundaries of human science and data science to create a healthier world.
