• Cautiously monitor clinical trials to ensure sponsor and investigator obligations are being met and in compliant with applicable local regulatory requirements and ICH-GCP guidelines• Assessed the qualification of potential investigative sites, initiated clinical trials at investigative sites, instructed site personnel on the proper conduct of clinical trial, and closed clinical trials at investigative sites• Reviewed and verified accuracy of clinical trial data collected, either onsite or remotely• Provided regular site status information to team members, trial management, and updated trial management tools• Completed monitoring activity documents as required by PRA SOPs or other contractual obligations• Worked closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues• Escalated site and trial related issues per PRA SOPs, until identified issues are resolved or closed • Performed source document verification and query resolution• Assessed IP accountability, dispensation, and compliance at the investigative sites• Verified Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines• Ensured all required training is completed and documented • Served as observation visit leader. Updated applicable tracking systems• Communicated with investigative sites• Facilitated audits and audit resolution• Performed essential document site file reconciliation• Served as observation visit leader• Mentored junior level CRAs and serves as a resource for new employees

• Participated in pre-study/initiation meetings with site investigators and study coordinators to ensure complete understanding of the clinical study objectives and data requirements. • Ensured delivery of all supplies and equipment to assigned study sites • Coordinated activities of associates and investigators to ensure compliance with protocol and overall clinical objectives. • Assisted in identifying study sites, developing feasibility questionnaires (with oversight from CSM or designee) and training documents for CRO personnel to perform pre-study visits. • Performed pre-study visits; reviewing study-related information with potential investigators (study synopsis, study logistics). Provide recommendations to the CSM on site selection• Worked under close supervision of a Clinical Study Manager, monitors clinical sites to ensure adherence to protocol (including appropriate patient selection) and safety requirements. • Provided necessary study updates to Clinical Management on a regular basis.• Performs study closeout visit activities ensuring that required documents are in order • Established and maintains working relationship with study coordinators and investigators at assigned study sites. • Ensured accuracy and completeness of the data in CRFs and resolution of data queries. Ensured electronic CRF completion and study data entry into internal tracking systems• Reported trends and observations noted at sites to study team. Ensures prompt processing of drug requests • Reviewed pharmacy drug accountability records; reviews and ensures updates to essential document/regulatory binders. Ensures that serious adverse event (SAE) data is reported to MDS• Ensured that Investigators have received and processed SAE information as required. Identifies protocol modifications as needed

• Developed, coordinated and supervised research and administrative activities of clinical research studies conducted by principal investigator(s) • Developed and oversaw a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data • Provided front desk support to the research department• Took orders for handling research activities• Performed research activities in accordance to the orders provided• Study research materials to ensure accuracy and relevance to orders• Performed filing and data entry duties• Summarize research findings and make appropriate presentations• Review medical records to ensure completeness and accuracy