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Facilitated site initiation visits for the purpose of training site personnel on the protocol, study procedures, patient recruitment and retention requirements, case report forms, completion and retention requirements, adverse events, reporting procedures, and overall management. Manage all aspects of clinical trials, including protocol development, site selection, initiation, monitoring, and close-out activities.Conduct pre-study, initiation, interim, and close-out site visits to… Show more Facilitated site initiation visits for the purpose of training site personnel on the protocol, study procedures, patient recruitment and retention requirements, case report forms, completion and retention requirements, adverse events, reporting procedures, and overall management. Manage all aspects of clinical trials, including protocol development, site selection, initiation, monitoring, and close-out activities.Conduct pre-study, initiation, interim, and close-out site visits to ensure compliance with protocol, regulatory requirements, SOPs, and ICH-GCP guidelines.Perform source data verification, review case report forms (CRFs), and resolve data discrepancies in a timely manner.To facilitate smooth trial conduct, develop and maintain strong relationships with investigational sites, study coordinators, and other key stakeholders.Provide training and support to site staff on protocol requirements, study procedures, and regulatory compliance.Coordinate with cross-functional teams, including clinical operations, regulatory affairs, and data management, to ensure timely and successful completion of clinical trials Show less

Responsible for the timely identification and escalation of site performance and quality issues to the Clinical Trial Lead (CTL).Conducted pre-study site evaluations and initiated, monitored, and closed clinical sites in accordance with ICH-GCP guidelines, SOPs, and study protocols.Collaborated with investigators, study coordinators, and site staff to ensureManaged all aspects of clinical trials from initiation to closeout, ensuring compliance with protocols, regulatory… Show more Responsible for the timely identification and escalation of site performance and quality issues to the Clinical Trial Lead (CTL).Conducted pre-study site evaluations and initiated, monitored, and closed clinical sites in accordance with ICH-GCP guidelines, SOPs, and study protocols.Collaborated with investigators, study coordinators, and site staff to ensureManaged all aspects of clinical trials from initiation to closeout, ensuring compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.Conducted site initiation, monitoring, and closeout visits, ensuring proper conduct of trials and adherence to study protocols.Developed and maintained excellent relationships with investigators, site staff, and study participants to facilitate smooth trial execution. Show less

Monitors drug inventory, dispensing, compliance, and return and ensures that used and expired medication are returned to the sponsor or disposed of per pharmacy guidelines.Training and re-training of new research personnel, including Study Coordinators, Investigators, and site pharmacists.Conducts site equipment inspection and site SOP to ensure patient safety and adherence to protocol, conducted site qualification, initiation, monitoring, and close-out visits for multiple clinical… Show more Monitors drug inventory, dispensing, compliance, and return and ensures that used and expired medication are returned to the sponsor or disposed of per pharmacy guidelines.Training and re-training of new research personnel, including Study Coordinators, Investigators, and site pharmacists.Conducts site equipment inspection and site SOP to ensure patient safety and adherence to protocol, conducted site qualification, initiation, monitoring, and close-out visits for multiple clinical trials in accordance with study protocols, regulatory requirements, and company SOPs.Managed study budgets, contracts, and payments to investigational sites, vendors, and consultants.Reviewed and monitored clinical trial data to ensure accuracy, completeness, and compliance with protocol and regulatory requirements.Implemented corrective and preventive actions as needed to address issues identified during site visits and monitoring activities. Show less

Performed site initiation, interim monitoring, and closeout study visits, and investigator meetings as assigned.Performed clinical trial implementation procedures and maintenance.Performed ECGs and obtained vital signs of patients.Dispensed study medication by following protocol requirements.

Bachelor'S Degree, Materials Engineering

Education record

Education record