• Managed quality assurance programs including on site evaluations, internal audits, and customer surveys.• Reviewed participant eligibility and documentation of consent.• Evaluated electronic data capturing systems for adherence to guidelines.• Checked drug storage procedures for compliance with protocols and SOP requirements.• Monitored collection, accuracy, and integrity of regulatory documents in site binder.• Ensures that drug accountability logs are kept and procedures on investigational products are followed.• Ensures that the PI and the site staffs have a proper understanding of the protocol, and re-train site staff on any violation of protocol.• Reconciles the Site Master File with the Trial Master File and• maintains site's regulatory binder and corresponding TMF.

• Manages and monitors different aspect of clinical trials according to the study protocol, SOPs, ICH-GCP and FDA guidelines for clinical trials.• Verify the qualification of potential clinical trial sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.• Prepares and reports the site status information to team members, trial management, and updates trial management tools.• Implements and monitors clinical research to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines.• Reviews and verifies accuracy of clinical trial data collected from investigative sites.• Verifies that Informed Consent forms are obtained, written and signed by the clinical trial subjects prior to their participation in the study. • Escalates site on trial related issues in accordance with sponsor's SOPs until the said issues are addressed or closed. • Ensures that sites report and document Adverse Event (AE), Serious Adverse Event (SAE) and all other safety issues appropriately. • Ensures sites are adhering to protocol and abiding by the inclusion and exclusion criteria as stated in the protocol.• Conducts site equipment's inspection and site SOP to ensure patient safety and adherence to protocol.• Ensures that drug accountability logs are kept and procedures on investigational products are followed.• Ensures that the PI and the site staffs have a proper understanding of the protocol, and re-train site staff on any violation of protocol. • Reconciles the Site Master File with the Trial Master File and also maintains site's regulatory binder and corresponding TMF.

• Performed various types of site monitoring visits including Pre-study visits, Qualification Visits, Initiation visits, Interim Monitoring Visits and Termination Visits. • Worked with sites to establish a robust site recruitment plan and track progress toward the accomplishment of recruitment targets. • Played an active role in the training of site personnel during Site Initiation Visits and Investigator Meetings.• Completed visit reports after each visit in accordance with monitoring plans.• Conducted ongoing monitor visits to conduct source data verification, drug accountability, query generation and resolution, SAE verification and reporting oversight, regulatory file review and oversight, document submission for central archiving, monitoring reports, general site support and communication.• Worked with sites to troubleshoot and resolve issues at the site.• Trained and re-trained new research personnel, including Study Coordinators, Investigators, and site pharmacists.• Monitored drug inventory, dispensing, compliance and return and ensure that used and expired medication are returned to the sponsor or disposed per pharmacy guidelines.• Conducted site closeout visits and tasks including test article reconciliation and disposition, review of accuracy and completeness of study files, and retrieval of all outstanding documents.

• Managed quality assurance programs including on site evaluations, internal audits and customer surveys.• Reviewed participant eligibility and documentation of consent.• Evaluated electronic data capturing systems for adherence to guidelines.• Checked drug storage procedures for compliance with protocols and SOP requirements.• Monitored collection, accuracy and integrity of regulatory documents in site binder.• Conducted initiation, monitoring and closeout visits.• Maintained compliance with protocols covering patient care and clinical trial operations.• Followed informed consent processes and maintained records.• Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.

• Assisted the Project Manager and the overall project management to ensure that sites adhere to the study protocol, ICH GCPs, and company SOPs.• Co-monitored responsibilities on-site under the assigned lead CRA's direction.• Analyzed and evaluated clinical data, to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, and ICH Good Clinical Practice (GCP) guidelines.• Reviewed regulatory documents and Essential clinical research documents required for study initiation.• Assisted team members and clinical team leader (CTL) with designated administrative tasks in support of clinical trial execution and management.• Assisted in maintaining and managing data entry into subject enrollment tracking systems.• Assisted in preparing, managing and distributing clinical documentation and reports as needed• Assisted with coordination and distribution of clinical trial supplies (excluding investigational products)• Managed case report forms (CRF) and clinical data flow• Collected data and followed research protocols, operations manuals and case report form requirements.