.Job Description : We are a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products.
The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space whereour company has codified its 125-year legacy.
Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Our company is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company.
Today, we're doubling down on this goal.Our research division is a true scientific research facility of tomorrow and will take our leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The role is accountable for performance and compliance for assigned protocols and sites in a country.
With support of Senior CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.Responsibilities:Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.Gains an in-depth understanding of the study protocol and related procedures.Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.Participates & provides inputs on site selection and validation activities.Performs remote and on-site monitoring & oversight activities to ensure:Data generated at site are complete, accurate, and unbiased.Subjects' rights, safety, and well-being are protected.Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner.Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance, and study close-out.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.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