Site Care Partner - Lead CRA - US - FSP

ALL US Locations
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The Site Care Partner (SCP) is the “face of the client” and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and client’s reputation is upheld throughout study lifecycle. The SCP is the main client point of contact for investigative sites; accountable for site start up activities through activation; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies;

accountable for site level recruitment and operational success, and accountable for safeguarding the quality and patient safety at the investigator site. The SCP contributes to country and site selection activities by proactively collaborating with key stakeholders and providing local intelligence to country outreach surveys, investigator strategies and client pipeline opportunities under supervision.

• Provides input into site recommendations via intimate understanding of country and region, sites, processes and practices, and associated site performance metrics

• Provides support to the Study Operations Manager (SOM)/Global Study Manager (GSM) to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies

• Deploys Global Site and Study Operations (GSSO) site strategies by qualifying and activating assigned sites

• Supports processes to optimize country and site selection activities including review and assessment of the draft potential site list and provide Pre-Trial Assessment (PTA) output for site selection

• Maintains a thorough knowledge of assigned protocols

• Conducts study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, Informed Consent Document (ICD) finalization, Site Initiation Visit (SIV), as applicable, including management of issues that may compromise time to site activation

• Ensures all the site initiation activities completed including training per site activation checklist, collect and complete necessary documentation and systems needed

• Supports country specific ICD review and deployment when applicable

• Ensures follow up activities are completed post PTA and SIV to ensure site readiness for First Subject First Visit (FSFV)

• Partners with site monitor to ensure site monitoring readiness in anticipation of FSFV

• Responsible for relationship building and operational oversight of the site Provides support for escalated site issues related to study delivery by coordinating communications and resolution efforts (e.g., vendor, site contracts and payment issues etc.)

• Ensures the strategy and approach for Investigational Product (IP) and ancillary supplies for sites and country requirement throughout the lifecycle of the study Accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets

• Responsible for enrollment support and ensures progress by responding to recruitment issues from investigators

• Maintains regular communications with investigator sites to gather status updates and drive delivery to study goals (e.g. recruitment, data entry timelines etc.)

• Partners with local Regulatory Authority (RA)/ Clinical Trial Regulatory Operations (CTRO) / Site Activation Partner (SAP) to ensure timely completion on country / local registry when applicable

• Acts as operational point of contact for all site level questions, liaising with and escalating to appropriate teams to respond and resolve questions

• Reviews site monitoring reports

• Supports the site with revision and…