Site Partner II
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
As a Site Partner II, you'll provide support across investigator sites in Colombia for study start-up and regulatory submission activities, including responsibilities such as:
Key Responsibilities
- Lead the preparation, compilation, and quality review of submission packages for Ethics Committee (EC/IRB) review, ensuring all required documentation is complete, accurate, and submitted within established timelines.
- Develop and execute regulatory strategies for Ministry of Health submissions, including COFEPRIS (Mexico) and other applicable local regulatory authorities, to support efficient approval pathways and study activation timelines.
- Coordinate with internal stakeholders, sponsors, investigator sites, and regulatory authorities to address queries, deficiencies,
and requests for additional information arising from Ethics Committee and Ministry of Health reviews.
- Provide regulatory guidance to investigator sites on local requirements, ensuring compliance with applicable regulations, ICH-GCP guidelines, and sponsor expectations throughout study start-up and maintenance activities.
- Monitor changes in local regulatory and ethics requirements, assess potential impacts on study timelines, and implement mitigation strategies to minimize activation delays.
- Maintain complete, accurate, and inspection-ready regulatory documentation within the Trial Master File (TMF) and other applicable systems in accordance with ICON quality standards.
- Support country-specific regulatory intelligence and contribute to process improvements that enhance study start-up efficiency, site engagement, and compliance.
These additions fit naturally with the existing responsibilities and highlight the regulatory
📌 Site Partner II (Bogotá)
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📍 Bogotá