Our leading pharmaceutical client is looking for a Clinical Operations Coordinator to join them on an initial 12 months contract
The successful applicant will be required to assists the clinical operations team in the operational management and oversight of clinical trials, during set-up, conduct and until archiving, for an assigned trial.
*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 the 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 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/review.
*Function as a Study Owner in the eTMF when required.
*Assist in reviewing and providing feedback of Standard Operations Procedures (SOPs), Working Instructions (WISs) and processes.
*Schedule and organize functional group meetings and/or events as needed.
*Support the Clinical Operations group as needed, including the Global Strategic Sourcing Group (e.g. Contracts execution and shipment, Resource Request management, coordination of the providers contracts, processing of invoices in the system).
*Perform other duties as assigned.
REQUIRED QUALIFICATIONS AND EXPERIENCE
*Minimum 3 years of clinical research experience (within pharma or CRO) / at international-global level.
* 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 (10%) may be required.
Key People is a specialist international recruitment consultancy with over 25 years' experience of working within the life sciences, biotech, healthcare and CRO industries. Our experienced and dedicated clinical research related consultants have a long history of success, excellent technical knowledge and a flexible, consultative focussed approach to recruitment.
Please contact Mark Cussens, Clinical Research Recruiter on
Tel: +44 1727 817623 or email: firstname.lastname@example.org
Tel: +41 4350 86620 or email: email@example.com
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