Parexel Uxbridge, England, United Kingdom
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Parexel FSP has an exciting opportunity for a Site Care Partner (Lead CRA) in the UK.
This is a home-based position with regular travel required across the UK.
Job Summary
The Site Care Partner (SCP) is the main client point of contact for investigative sites throughout a study lifecycle. They are accountable for site start-up activities, building and maintaining investigator site relationships, supporting from site recommendation through study completion, and safeguarding quality and patient safety at the investigator site.
The SCP contributes to country and site selection by collaborating with stakeholders and providing local insights for surveys, strategies, and pipeline opportunities. Acting as the "face of the client," the SCP ensures sites receive support, issues are resolved, and the client's reputation is maintained throughout the study lifecycle. They coordinate with other roles interfacing with study sites to optimize communication and confidence in site activities.
The SCP oversees site activities using data analysis and local intelligence to identify risks and develop mitigation plans.
Job Responsibilities
Accountable for site start-up and activation
* Qualify and activate sites following GSSO strategies.
* Support site and country selection processes, including review of site lists and providing PTA outputs.
* Collaborate on protocol feasibility, country practices, and outreach surveys.
* Conduct start-up activities like PTA, activation checklist, SIV, and manage related issues.
* Ensure completion of site initiation activities, including training and documentation.
* Support ICD review and deployment.
* Follow up post-PTA and SIV to ensure site readiness.
* Coordinate with site monitors for readiness for first visit.
* Support escalated site issues and coordinate resolutions.
* Manage site-level recruitment planning and delivery.
Accountable for study conduct and close-out
* Serve as operational contact for site questions, escalate as needed.
* Review monitoring reports and support documentation submissions.
* Maintain system management for study data and site information.
* Review and update site management assessments.
* Manage site practices and ensure quality and compliance.
* Maintain communication with sites for updates and feedback.
* Oversee site deliverables and study milestones.
* Implement risk mitigation strategies.
* Support decentralized capabilities at sites.
* Ensure quality and efficiency in monitoring practices.
* Enhance client reputation through local development efforts.
* Act as a subject matter expert on client systems.
* Identify efficiencies and best practices for site performance.
* Develop positive investigator relationships and escalate training or compliance issues.
Proactively provide local intelligence
* Contribute to site recommendations based on local knowledge and performance metrics.
* Support import/export processes of investigational products and supplies.
Knowledge And Experience
* Effective communication skills with stakeholders.
* Adaptability to changing technologies and processes.
* Networking and relationship management skills.
* Experience in site management and monitoring.
* Knowledge of quality and regulatory requirements.
* Understanding of GCP/ICH guidelines.
* Ability to travel up to 50% regularly.
* Proficiency in local language; English required.
Education
* Bachelor’s degree or RN in a related field, or equivalent experience (~5 years).
Additional Information
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