Job Duties:

• 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
• Performs remote and on-site monitoring & oversight activities using various tools to ensure:

                -Data generated at site are complete, accurate and unbiased
                -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
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Support and/or leads audit/ inspection activities as needed.
• Study document management; regulatory & site start-up responsibilities
• Primary Medical Review of promotional materials in compliance with company policy, local standards and regulations
• Any adhoc projects under medical affairs department