Jobs in Kottayam

Site Care Partner

Role Summary

The Site Care Partner is the main client's point of contact for investigative sites throughout a study life cycle; 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 Site Care Partner 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. The Site Care Partner is the “face of 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. Additionally, the Site Care Partner will coordinate with other roles and functions that will interface with study sites (eg. Study Monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.) thereby, optimizing communications and enhancing overall visibility into and confidence of quality of site level activities. The Site Care Partner is responsible for site oversight utilizing and interpreting data from analytic tools, in conjunction with country intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks.

Responsibilities

Accountable for site start-up and activation :

• Deploy GSSO site strategies by qualifying and activating assigned sites
• Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection.
• Collaborate with key stakeholders providing country / regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable) under supervision.
• Maintain a thorough knowledge of assigned protocols
• Conduct study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation.
• Ensure all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation / systems needed for site activation. (e.g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF / eISF etc.)
• Support country specific ICD review and deployment when applicable
• Ensure follow up activities completion post PTA and SIV to ensure site readiness for FSFV
• Partners 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
• Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts. (e.g., vendor, site contracts and payment issues etc.)
• Ensure the strategy / approach for IP and ancillary supplies for sites and country requirement throughout the lifecycle of the study
• Be accountable for effective site recruitment planning and delivery, consistent with global and / or country plan and local targets; Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators.
• Maintain regular communications with investigator sites to gather status updates and drive delivery to study goals (e.g. recruitment, data entry timelines etc.).
• Partner with local RA / CTRO / SAP to ensure timely completion on country / local registry when applicable

Accountable for study conduct and close-out

Responsible for proactively providing local intelligence

Qualifications

Training and Education

Prior Experience

Technical Competencies

Behavioral Competencies