Clinical Trial Capabilities Specialist
2 days ago
Develop your expertise in clinical trial capabilities to support the development of new treatments. This role involves providing critical support to investigator sites, ensuring they meet requirements for enrolling study participants and maintaining ongoing activities during site maintenance and close-out.
As a Trial Capabilities Associate, you will be responsible for initiating investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, and serving as the point of contact for a site's ERB and Competent Authority (where applicable).
You will communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out. Additionally, you will identify, communicate, and resolve issues, ensuring country-specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems.
Key Responsibilities:
- Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site's ERB and Competent Authority (where applicable), communicate and negotiate budgets with site personnel and internal teams, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities
- Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
- Identify, communicate, and resolve issues
- Ensure country-specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
- Leverage previous site/review board engagements to efficiently drive new work
- Populate internal systems to ensure accuracy of trial/site performance
- Understand and comply with procurements, legal, and financial requirements and procedures
- Populate Trial Master Files and libraries for future reference
- Provide feedback and shared learning for continuous improvement
- Leverage trial prioritization
- Anticipate and monitor dynamically changing priorities
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