● 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.● Performs ongoing review of Investigator’s Trial File to assure quality of the documentation files, completion, and compliance with company SOPs, GCP and ICH Guidelines while on site.● Reviews on-site files, product accountability logs, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies and provides remedial training and/or corrective action as the need arises.● Provides site support for remote/electronic data capture (EDC), reviews for completeness and consistency, and generates and resolves queries in between monitoring visits.● Demonstrates strong leadership and collaboration skills in cross-functional teams.● Mentors and trains junior clinical research associates on industry standards and regulations● Achieves 100% compliance with regulatory agencies during site audits and inspections.● Perform the clinical monitoring aspect of designated projects in accordance with study specific procedures, applicable SOPs, and regulations.● Acts as direct contact with assigned clinical sites and uses judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites. Applies expertise and independent judgment to independently verify patient safety and patient rights. Assists with the development of protocol writing, informed consent development, CRFs, monitoring conventions, tracking forms, and other study related documents.● Assists in managing and/or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.

Identified and assessed the suitability of clinical study centers for participation in clinical trials.● Ensured the completion and collection of regulatory documents.● Evaluated and reported site performance and protocol compliance.● Assisted clinical centers with the preparation of IRB/EC submissions.● Collected and archived study-related documentation and correspondence.● Communicated monitoring and site management updates to the internal clinical team.● Developed training materials and other study-related documentation.● Maintained clinical monitoring tracking tools for each clinical study.● Provided monitoring visits and site management for a variety of protocols, sites, and therapeutic areas.● Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues.● Performed clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, and data collection)● Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.Good understanding of everyday working of ICH and implementation. ● Completed the monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies, and recommended action to secure compliance.

Managed clinical research studies, including recruiting and screening study participants, obtaining informed consent, administering study interventions, and collecting data from study participants. Site management and research team coordinator on site ● Ensured that all study data is collected accurately and entered into the study database in a timely manner. ● Ensured that data is stored securely and in compliance with regulatory requirements. ● Responsible for ensuring that all study activities comply with relevant regulatory requirements, including FDA regulations, GCP guidelines, and institutional policies and procedures.● Ensured the safety and well-being of study participants, including monitoring adverse events and implementing appropriate interventions when necessary.● Served as the primary point of contact for study participants, study staff, and study sponsors. ● Responsible for coordinating study activities, including scheduling study visits and coordinating study procedures.● Ensured that study procedures are conducted according to the study protocol and standard operating procedures.● Ensured that all study documentation is complete and accurate