I am a CRA at a pharmaceutical company and enjoy helping people improve 
their lives. At leisure, I love to read and socialize with friends.

Baruch College

•         Perform monitoring visits (qualifying, initiation, maintenance/management, closeout) and collect, review study and site documents; including site regulatory binder and escalate discrepancies.
•         Upload trial documents such as Protocol and Amendments, Consent Forms, IRB Approvals.
•         Track and collate documentation related to the Clinical Study Report (CSR) appendices and prepare agreements, ie CSA and CDA.
•         Confirm receipt of letters (confirmation letters and follow up letters) for scheduled visits and complete monitoring visit reports.
•         Provide adequate protocol training to sites, including investigator, during initiation visits.
•         Identify sites to determine if they are able to conduct trials based on past experience.
•         Review source documents and case report forms (CRF) for data consistency and resolve discrepancies; ensure GCP guidelines are followed and protocol adherence by study site personnel.
•         Identify, report and record protocol deviations and CAPA for site compliance including subjects’ safety.
•         Review and record any adverse, serious events, concomitant medicines and illness relations and escalate as needed.
•         Manage site and staff documents (licenses, 1572, CVs, ICFs and certificates) to ensure they are current/active.
•         Review documents for consistency and compliance with regulatory requirements by supporting compliance department.
•         Negotiate and create budgets for multiple study protocol and sites.
•         Prepare and submit regulatory documents to IRB and ensure submissions are up-to-date.
•         Review regulatory, lab and pharmacy binders periodically for audit inspection readiness.
•         Track clinical site and internal study team personnel (active versus inactive) and update associated lists to provide access or de-activate access to clinical systems.

RESUME12042023.docx

Sangeeta Tripathi

English

Hindi

Native or bilingual proficiency

Manager

Veeva Vault

ICH guidelines

EPIC

Ability to collaborate and communicate within a cross-functional team including managers, technical leads and system engineers Professional demeanor and positive attitude

Ability to work independently and as a team.

complex problem solving

Strong Team Player

Sangeeta Tripathi

#1 Video-Talent Marketplace

Ready to discover your perfect career?