Site Care Partner

hace 4 semanas

San Juan, San Juan, Puerto Rico Jobleads-Us A tiempo completo
Job Summary

The Site Care Partner is a critical role that serves as the main client point of contact for investigative sites throughout a study life cycle. This individual is accountable for site start-up activities through activation, building and retaining investigator site relationships, and providing support from site recommendation through the lifecycle of studies. The Site Care Partner is responsible for site-level recruitment and operational success, as well as safeguarding the quality and patient safety at the investigator site.

Key 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
  • Collaborate with key stakeholders providing country/regional level input to country outreach surveys
  • Maintain a thorough knowledge of assigned protocols
  • Conduct study start up activities at the site level
  • Ensure all the site initiation activity including training per site activation checklist
  • Support country specific ICD review and deployment when applicable
  • Partners with site monitor to ensure site monitoring readiness
  • Responsible for relationship building and operational oversight of the site
  • 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
  • Be accountable for effective site recruitment planning and delivery
  • Maintain regular communications with investigator sites to gather status updates and drive delivery to study goals
  • Partner with local RA/ CTRO / SAP to ensure timely completion on country / local registry when applicable
  • Accountable for study conduct and close-out
  • Act as operational point of contact for all site-level questions, liaising with and escalating to appropriate teams to respond and resolve questions
  • Review Site Monitoring Reports
  • Support the site with revision and submission of ICD documents (and amendments)
  • Working with other roles, maintain system management at site level ensuring alignment across platforms
  • During the conduct of the study, the Site Management Organization Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed
  • Review and manage site practices that differ from client practices and liaise with study management and Business Process Owners as needed
  • Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback
  • Inform and educate investigator sites of client pipeline opportunities that may be a good fit
  • Oversight and management of site deliverables to study targets
  • Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks
  • Assure quality and consistency in the delivery of monitoring
  • Drive monitoring efficiencies and best practices for study/region/program
  • Demonstrate leadership within the local clinical development environment with a goal to enhance client reputation in scientific leadership
  • May act as a Subject Matter Expert on client systems and processes
  • Actively pursue possible efficiencies and develop best practices in the delivery of activities for site performance throughout the life cycle to increase investigator/site satisfaction and strengthen site relationships
  • Ensures clear and open communication with Study Operations Manager
  • Support the site monitor to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Country Trials Manager and Study Management
  • Responsible for proactively providing local intelligence
  • Provide input into country strategy/planning and site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics
  • Provide input to cluster level intelligence for site strategy and support implementation of cluster-level strategy in collaboration with the Study Operations Manager/Global Study Manager
  • Provide regional exploration/territory development growing adjacent opportunities where possible
  • 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
Requirements
  • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 7 years experience)
  • Proficiency in local language preferred. English is required
  • Willingness to travel up to 70-75%

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