Debabrata Sahoo

• Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. • Manage and lead cross-functional study teams, including vendors; liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, and regulatory affairs) in order to accurately coordinate clinical study activities. • Coordinate clinical study timelines with Project management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables. • Conduct study monitoring visits and co-monitoring visits as needed. • Provide regular updates of study progression to Clinical Development Lead, Program Management, and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues. • Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables. • Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team. • Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans. • Author, audit and/or edit written summaries of data reports, presentations, training material, and study documents (including pharmacy, laboratory, and operations manuals). • Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members. • Provide oversight and direction to study team members, including vendors, for study deliverables. • Coordinate with finance to track the financial status against budget.

As a Senior Research Associate-Site Operation I have experience in multicentric studies. •Design, plan, conduct and coordinate experiments in support of various research projects. •Manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs. •Reviews study data, Case Report Forms (CRFs) or Electronic Case Report Forms (eCRFs), against site source documentation and discusses discrepancies with investigative site staff. •Communicates with  assigned  clinical  research  investigators  and  staff  on  a  regular  basis, documenting the correspondence as per the study specific guidelines. •Ensure accurate and timely reporting and follow up of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations. •Reviews regulatory documentation/file at the site for completeness, collects updated forms as applicable. •Overseeing and documenting IP dispensing inventory, and reconciliation. •Skilled In- -Good Clinical Practice. -Review Electric Data Capture & Paper CRF As per the subject Source. -Patient Tracking as per schedule Visit. -Coordinates participant tests and procedures. -Review the Dispensed Medicine As per IWRS. -Maintains study timelines. -Review Visit specific activities. -Safety guidelines and reporting timelines as per the protocol. -Maintains subject screening logs and protocol deviation logs. •Assists the Principal Investigator in submission of accurate and timely closeout documents to the sponsoring agency in accordance with university and sponsoring agency policies and procedures.

As a Clinical Research Coordinator I have experience in multicentric studies. Like: •Coordinates approval of new study agreements and contracts. •Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP and applicable regulatory requirement •Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion. Assists in preparation of all documents related to the informed consent process. •Skilled In- -Good Clinical Practice. -Electric Data Capture & Paper CRF -Patient Tracking as per schedule Visit. -Coordinates participant tests and procedures. -Dispensed Medicine As per IWRS. -Maintains study timelines. -Visit specific activities. -Collects specimens & Send to the Central Lab. -Safety guidelines and reporting timelines as per the protocol. -Maintains subject screening logs and protocol deviation logs. •Assists the Principal Investigator in submission of accurate and timely closeout documents to the sponsoring agency in accordance with university and sponsoring agency policies and procedures.

Trainee