• Coordinates all the necessary activities required to set up and monitor a study, including but notlimited to the following: Conduct pre-study visit, assess study site to ensure, facility, patientpopulation and staff are sufficient to support the protocol.• Responsible for site management oversight, clinical monitoring deliverables with a focus on patientsafety, protocol/GCP/regulatory compliance, and data integrity.• Ensures consistency of all study processes across regions.• Manages project teams in the region, including team building, quality compliance, training andmonitoring of daily activities.• Involves in decision-making regarding site monitoring and CRF review.• Contributes to the development and update of project planning documents, essential documents,and project instructions.• Meets with PI and staff to review study requirements (protocol, CRFs, Sponsor policy andprocedures, investigator responsibilities, staffing and patient recruitment) and conducts studyinitiation visit.• Trains the site on the CRF completion, on the protocol and safety reporting procedure.• Collects and forwards all required study documentation to Sponsor or JSS.• Documents visit and send a copy of the report to the site and conduct routine monitoring visits toinclude.• Verifies the source data and ensures that it is accurately reflected in the Case.• Resolves questions by Investigator/Staff and ensures the validity of the queries sent to the site by thedata management.• Ensures that all consents (if applicable) are signed by the patient prior to study entry.• Collects all regulatory documents such as CV, MD licenses, IRB approvals etc and conducts close outvisits to include.

Responded to site issues identified during monitoring visits (i.e., non-responsive site, ProtocolDeviations concerns, and quality issues).• Obtained consents, signature, and other required documentation.• Tracked Serious Adverse Events at assigned sites and ensured timely reporting to the sponsor andIRB.• Performed documentation and monitoring of all clinical research trial data.• Conducted protocol training to staff at investigator site(s) during site initiation visit, to ensure thatsite(s) is/are equipped to conduct the clinical study.• Performed site visits which includes - site qualification, initiation, monitoring and close-out visits.• Performed and coordinated assigned aspects of the clinical monitoring process in accordance withGCPs and global SOPs to assess the safety and efficacy of investigational products and/or medicaldevices.• Reviewed protocol violations with investigators and implemented corrective actions to ensure futurecompliance with the protocol and applicable regulations (FDA/GCP/ICH/IRB)

• Provided general administrative support to the Clinical Operations Department and assistance toProject Manager(s) and Project Director(s).• Assisted the Clinical Operations teams in completion of all required tasks to meet departmental andproject goals.• Set up, organized and maintained clinical study documentation (e.g. Main Study Files, CRFs, etc.)including preparation for internal/external audits, final reconciliation and archival.• Assisted project teams with trial progress tracking by updating the Clinical Trial Managementsystems.• Contacted clinical sites for specific requests for enrollment updates, missing documentation, meetingarrangements and so on.• Assisted in the tracking and distribution of safety reports.• Assisted the Project Manager and project team with Investigator Meeting coordination, activitiespreparation and generating meeting minutes.• Worked with various study staff on site and gathered all required documents.• Collaborated with site staff to monitor all data and make required travel arrangements.• Maintained records and logs of all clinical research programs and assisted in filing and preparingpresentations in both media and graphic format.