Accountable for site start-up and activation
Deploy Global Site and Study Operations ( 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 Pre-Trial Assessment ( 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
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
Support country specific ICD review and deployment when applicable
Ensure follow up activities’ completion post PTA and SIV to ensure site readiness for FSFV
Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts

Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience (estimate at least 5 years’ experience)
Ability to communicate effectively and appropriately with internal & external stakeholders
Ability to adapt to changing technologies and processes
Demonstrated networking and relationship building skills and to manage cross functional relationships
Demonstrated experience in site management with prior experience as a site monitor
Demonstrated experience in full lifecycle activities from start-up/site activation through to closeout
Demonstrated knowledge of quality and regulatory requirements for the country the role is based
Knowledge of Good Clinical Practice (GCP)/International Council for Harmonization (ICH) Guidelines and other applicable regulatory requirements
Ability to manage required travel of up to 75% on a regular basis
Proficiency in local language. English is required.

Site Care Partner – Lead CRA

Key skills