Site Care Partner - Mexico

Job 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.

• Supports the Feasibility Strategy and Analytics Lead to ensure that high quality feasibility results are delivered

• Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable).

• Provide country/regional level input to country strategy, feasibility, and protocol design in collaboration with relevant Medical Affairs colleagues, and with input from external clinical experts as required. 

• 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 eg. 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

• 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 (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, the Site Management Organization Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed. In addition, the SMO Assessment is reviewed and updated when major staffing, contracting, or other significant site changes/issues occur to confirm that continuity and contingency plans are current. 

• 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, i.e. data cuts/sweeps, interim analyses, database locks, helping to oversee data is up to date and any other site-facing deliverables, i.e. investigator signatures. 

• Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.

• 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.

Education

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 5-7 years experience)

• Proficiency in local language preferred. English is required

• Willingness to travel up to 70-75%