- Reviewed all AEs/SAEs to ensure appropriate documentation is in place and any other safety issues addressed.- Collaborate with Remote Site Monitors (RSM), Clinical Trial Coordinator- Central and Local (CTC-C andCTC-L) to provide all site needs, questions and concerns and access to systems etc.- Utilised multiple EDCs, eTMF, IRB.- Supported data validation and data cleaning procedures to ensure timelines are met.- Managed patients recruitment strategies to increase patient randomisation into the trial.- Ordered and coordinated study supplies for clinical studies.- Responsible for evaluation, initiation, monitoring, close-out and other tasks associated with the management of clinical sites.- Supported feasibility and site selection process for clinical studies.- Planned and participated in investigator meetings and CRA trainings.

- Ensure the conduct of clinical studies are in accordance with protocols and GCP guidelines.- Prepared and tracked technical documentation including IRB submissions/approvals, ICFs, CRFs, site trainings, etc.- Review and Reconcile source documentation.- Maintain drug accountability to ensure product availability for patients and sites.- Direct system vendors for the tailoring and implementation of EDC, CTMS, and eTMF functions.- Track site status for start-up and maintenance as well as essential documents for proper protocol adherence.- Conduct on-site monitoring visits for site training and source data verification.- Ensured delivery of all supplies and equipments are assigned to specific study sites.- Established and maintained working relationship with study coordinators and investigators at various assigned study sites.- Performed billable work in accordance with company policies, procedures, and standard operating procedures.- Coordinated activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.- Ensured completeness and accuracy of data in the CRFs and resolutions of data queries.

- Performed clinical trial implementation procedures and maintenance.- Performed ECGs and obtain vital signs of patients.- Discuss study protocol with patients and verify the informed consent documentation.- Conducted study start-up activities and prepared and maintained all regulatory documentsrequired by sponsor and/or regulatory agencies.- Prepared protocols, informed consent documents, modifications, renewals and othernecessary documents for review by the IRB and/or sponsor.- Coordinated study conduct with other departments to effectively implement clinicalresearch projects; obtains required letters of support and/or approvals as needed (i.e. IBC,SRC, etc.) and protocol is followed.- Identified and recruited eligible study subjects; conducts informed consent/assentprocess.- Arranged and conducted clinical research visits.- Conducted literature searches and assisted with QA/QC procedures.- Monitored/assessed adverse events and reported them as required.- Adhered to research protocol in compliance with applicable institutional, local andfederal regulations (OHRP, FDA, GCP, etc.).