Clinical Operations Coordinator
Our client is a leading biopharmaceutical company is currently looking for a Clinical Operations Coordinator, who will assist the Clinical Operations team in the operational management and oversight of clinical trials, during set-up, conduct and until archiving, for an assigned trial.
- Coordinates the preparation and/or review of all operation trial-related documents (e.g., forms, guidelines) and site related documents (e.g., Investigator Site Files [ISF])
- Coordinates the preparation and distribution of clinical study documentation (e.g., site communication, newsletters, pocket brochures, appendix 16 for the CSR)
- Coordinates the delivery and inventory of study related non-clinical supplies (ordering, distribution, tracking, expiry dates management, resupplies)
- Coordinates site contracts finalization and execution
- Coordinates Insurance certificates for the trial in collaboration with legal department
- Ensures completeness and maintenance of key trial information in the CTMS
- Files, uploads and QCs 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/review
- Functions as a Study Owner in the eTMF when required
- Assists in reviewing and providing feedback of Standard Operations Procedures (SOPs), Working Instructions (WISs), Instructions, and processes
- Performs other duties as assigned
- Schedules and organizes functional group meetings, events
- Support the Clinical Operations group as needed, including the Global Strategic Sourcing Group (e.g. Contracts execution and shipment, support in flexible resourcing management and Resource Request management, coordinate CRO/ESP and other providers contracts).
Qualifications and Experience:
- Minimum of 3 years of clinical research related experience with knowledge of applicable regulations and guidelines, e.g. ICH-GCP
- Strong computer skills and familiarity with Windows-based applications (e.g., Word, Excel Power Point, and Access)
- Demonstrated ability to comprehend detailed instructions and accurately follow directions
- Strong organizational and time management skills
- Detail oriented with the ability to handle and prioritize multiple tasks
- Quality conscious
- Team player
- Strong English written and verbal skills.
- Relevant working/residency permit or Swiss/EU-Citizenship required.