Nacre Capital
Nacre Capital is a global venture builder specialized in creating, building and growing disruptive start-ups with deep technologies that significantly impact lives$1. .$1
Artificial Intelligence • Start-Ups • Deep Learning • Technology • Innovation
11 - 50
Clinical Operations Coordinator
June 3
Nacre Capital
Nacre Capital is a global venture builder specialized in creating, building and growing disruptive start-ups with deep technologies that significantly impact lives$1. .$1
Artificial Intelligence • Start-Ups • Deep Learning • Technology • Innovation
11 - 50
Description
• Oversee and manage study administration in accordance with Good Clinical Practice (GCP) guidelines • Coordinate and oversee all study-related tasks to ensure efficient execution and adherence to timelines • Interface with Institutional Review Boards (IRBs) to draft submissions, obtain approvals and ensure ongoing compliance • Create and maintain Trial Master File (TMF) and related records • Establish and maintain effective communication channels with study sites • Facilitate contract negotiations with study sites, ensuring compliance with regulatory and organizational standards • Provide training to site personnel • Develop and implement data collection strategies and processes in collaboration with study teams • Monitor and ensure the quality and completeness of collected data • Support study protocol creation while representing GCP and regulatory considerations and procedural aspects • Collaborate cross-functionally with Clinical Affairs, Medical Affairs and Regulatory Affairs teams throughout the planning and execution phases • Coordinate the closure activities of clinical trials in compliance with regulatory requirements • Compile study documentation for archiving and regulatory submissions
Requirements
• Bachelor's degree in a relevant field (e.g., life sciences, nursing, pharmacy, medical sciences) • Proven experience in clinical affairs within the medical device, preferable software experience • In-depth knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements related to clinical trials • Strong organizational, operational and communication skills • Ability to manage multiple tasks and prioritize effectively • Familiarity with data collection systems and electronic data capture tools – advantage • Excellent verbal and written English • CRA certificate – advantage
Benefits
• Generous paid sick time • Excellent verbal and written English
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