Sr. CRA - Clinical Research Associate

Sr CRA- 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 using various tools to ensure: o Data generated at site are complete, accurate and unbiased. o Subjects’ right, 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. • Works in partnership internally 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. • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. • Supports and/or leads audit/inspection activities as needed. • Following the country strategy defined by CRD and CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities. • Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate. • Could perform Quality control visits if delegated by other roles and trained appropriately. CORE Competency Expectations: • Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. • Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. • Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. • Demonstrated ability to mentor/lead. • Hands on knowledge of Good Documentation Practices. • Proven Skills in Site Management including independent management of site performance and patient recruitment. • Demonstrated high level of monitoring skill with independent professional judgment. • Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices • Ability to understand and analyze data/metrics and act appropriately, also in a virtual environment. • Experience with conducting site motivational visit designed to boost site enrollment. • Capable of managing complex issues, works in a solution-oriented manner. • Performs