Based in the heart of London, our client is a global pharmaceutical company focused on developing first class therapeutics.
They require a Clinical Study Coordinator with 3+ years of experience to join them on a 12-month contract to contribute to or lead tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead. This may include contributing to and/or supporting study related matters that impact study participant safety, data integrity, study timelines, quality, and budget.
Location: London/Hybrid (3 days a week remote/2 day onsite)
Contract Type: (Inside IR35)
BBBH: 24625
Responsibilities:
- Develop study specific documentation, as delegated by the Study Manager
- Contribute to the oversight of country and site feasibility assessment and site selection.
- Oversight of CRO for IRB/EC related submission/approval activities
- Oversight of essential documents for study life-cycle management
- Develop/Oversee site and investigator training materials
- Present at investigator meetings as assigned
- Ensure accurate and timely study entry and updates to ClinicalTrials.gov
- Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
- Process documents for signature in DocuSign
- Oversight of Clinical Trial Insurance
- Attend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.
- Oversee and manage essential documents in the Trial Master File (TMF)
- Contribute to Global Study Operations risks identification and mitigations.
- Provide support and administrative assistance with internal and external meetings
Requirements:
- 3+ years of relevant experience
- Phase IV / Post-Marketing experience
- A degree in nursing, life or health sciences is preferred. Relevant industry experience in lieu of education may be considered.
- Demonstrated experience in overseeing external vendors such as CROs, central labs, and imaging vendors.
- Proficient knowledge of study management and execution, compliance and quality, drug development and study design, and product and therapeutic area knowledge.
- Experience in developing study-specific documentation and overseeing country and site feasibility assessment and site selection.
- Ability to oversee CRO for IRB/EC related submission/approval activities.
- Experience in facilitating Screening Authorization Forms sign off and overseeing tracking where applicable
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