Clinical Operations Coordinator

Job Responsibilities

• Assist the clinical operations team in the operational management and oversight of clinical trials, during set-up, conduct, and until archiving, for assigned trials.
• Coordinate the preparation and / or review of all operational trial-related documents (e.g., forms, guidelines).
• Coordinate the preparations and / or review of site-related documents (e.g., Investigator Site Files (ISF)).
• Coordinate the preparation and distribution of clinical study documentation (e.g., site communication, newsletters, pocket brochures, appendix 16 for the Clinical Study Report (CSR)).
• Coordinate the delivery and inventory of study-related non-clinical supplies (ordering, distribution, tracking, expiry dates management, resupplies).
• Coordinate site contracts finalization and execution.
• Coordinate Insurance certificates for the trial in collaboration with the legal department.
• Ensure completeness and maintenance of key trial information in the Clinical Trial Management System (CTMS).
• File and upload documents in the different systems as needed.
• Ensure accurate maintenance and archiving of the electronic Master File (eTMF) within the required timelines and contribute by performing ongoing quality checks / reviews.
• Function as a Study Owner in the eTMF when required.
• Assist in reviewing and providing feedback on Standard Operations Procedures (SOPs), Working Instructions (WISs), and processes.
• Schedule and organize functional group meetings and / or events as needed.
• Support the Clinical Trial Teams, including the Global Strategic Sourcing Group as needed (e.g., issuing confidentiality agreements (CDAs), contracts execution and shipment, issuing change orders, Resource Request management, coordination of provider contracts, processing invoices in the system).
• Perform other duties as assigned.

Requirements

Candidate's Requirements

• Minimum 2 years of clinical research experience is preferred.
• Strong English written and verbal skills.
• Ability to work independently.
• Ability to effectively handle multiple priorities in a fast-paced environment.
• Ability to find effective solutions when faced with difficult situations and to implement team decisions.
• Strong computer skills, including proficiency in Microsoft (MS)-based applications (e.g., Word, Excel, and PowerPoint).
• Some overnight travel (
Il y a 1 jour