Site Care Partner
3 weeks ago
The Site Care Partner is the primary point of contact for investigative sites throughout a study lifecycle, responsible for site start-up activities through activation, building and retaining investigator site relationships, and providing support from site recommendation through the lifecycle of studies. This role is accountable for site-level recruitment and operational success, as well as safeguarding the quality and patient safety at the investigator site.
Key Responsibilities- Deploy site strategies by qualifying and activating assigned sites, supporting processes to optimize country & site selection activities, and collaborating with key stakeholders to provide country/regional level input to country outreach surveys.
- Conduct study start-up activities at the site level, including PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), and management of issues that may compromise time to site activation.
- Ensure all site initiation activity, including training per site activation checklist, collection and completion of necessary documentation/systems needed for site activation, and follow-up activities completion post PTA and SIV to ensure site readiness for FSFV.
- Partner with site monitor to ensure site monitoring readiness in anticipation of first subject first visit, responsible for relationship building and operational oversight of the site, and provide study support on escalated site issues related to study delivery.
- Ensure the strategy/approach for IP and ancillary supplies for sites and country requirement throughout the lifecycle of the study, and be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets.
- Maintain regular communications with investigator sites to gather status updates and drive delivery to study goals, and partner with local RA/CTRO/SAP to ensure timely completion on country/local registry when applicable.
- Act as operational point of contact for all site-level questions, liaising with and escalating to appropriate teams to respond and resolve questions, and review Site Monitoring Reports.
- Support the site with revision and submission of ICD documents (and amendments), and work with other roles to maintain system management (e.g., EDC, Shared Investigator Platform, Site Profile and other systems as applicable) at site level ensuring alignment across platforms.
- During the conduct of the study, review and manage site practices that differ from client practices, and liaise with study management and Business Process Owners as needed, and maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
- Oversight and management of site deliverables to study targets, i.e. data cuts/sweeps, interim analyses, database locks, and follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
- Provide input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics, and provide support to the Study Operations Manager/Global Study Manager to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies.
- Bachelor's degree in a scientific field, minimum of 5 years independent monitoring experience, ideally oncology study experience, but not essential, and proficiency in local language preferred. English is required.
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