Clinical Research
4 weeks ago
Clinical Research Specialist
Background: Our client is a small medical device and aesthetics manufacture that focuses on breast reconstruction clinical studies. They have a long-term IDE study that is approaching launch, and they are looking for an in-house specialist to come on and help with long-term patient and clinical site retention. This is a project-based role where knowledge with vendor and project management will be utilized.
Responsibilities:
- Development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports)
- Coordination and execution of ordering, tracking, and managing investigational products and trial materials;
- Interface and collaborate with IRBs/ECs, contractors/vendors, and company personnel
- Assist in overseeing the development and execution of Investigator agreements and trial payments
- Assist in clinical data review to prepare data for statistical analyses and publications
- If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center
- Responsible for communicating business related issues or opportunities to next management level
- Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
- Assist in tracking assigned project budgets
- Develop a strong understanding of the pipeline, product portfolio and business needs
Required Skills:
- Long-term clinical studies
- In-house clinical research activities
- Long-term site & patient retention
- Vendor Management
- Project Management
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