<h3>Job Description</h3><p>The role is accountable for performance and compliance for assigned protocols and sites in a country.</p><p>Under the oversight of the CRA-Manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.</p><p>Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.</p><p>Actively develops and expands the territory for clinical research, finding and developing new sites.</p><p>Participates in internal meetings and workstreams as SME for monitoring processes and</p><h3>Systems.</h3><h3>Responsibilities include, but are not limited to:</h3><ul><li><p>Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.</p></li><li><p>Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws &amp; Regulations, Protocol, Site Monitoring Plan and associated documents.</p></li><li><p>Gains an in-depth understanding of the study protocol and related procedures.</p></li><li><p>Coordinates &amp; manages various tasks in collaboration with other sponsor roles to achieve Site Ready.</p></li><li><p>Participates &amp; provides inputs on site selection and validation activities.</p></li><li><p>Performs remote and on-site monitoring &amp; oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased and subjects’ right, safety and well-being are protected.</p></li><li><p>Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit &amp; non-visit contact reports appropriately in a timely manner.</p></li><li><p>Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.</p></li><li><p>Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.</p></li><li><p>Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed.</p></li><li><p>Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.</p></li><li><p>Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.</p></li><li><p>Contributes to CRA team knowledge by acting as