Neethu Anna Stephen
Pharmacy Grad Intern|| FPGEC CERTIFIED|| Clinical Research Professional| Trial Master File Management
- Role
- Foreign Pharmacy Grad - International Intern at Cvs Pharmacy
- Location
- Sacramento, CA, US
- LinkedIn followers
- 500 followers
About Neethu Anna Stephen
I am a Foreign Pharmacist (FPGEC Certified) currently pursuing licensure in USA. The knowledge that I have gained from my PharmD degree coupled with the experience working as a Clinical Trial Coordinator has driven in me a desire towards research and patient safety.ROLES PERFORMED:Project Support Coordinator - II/ Clinical Trial Coordinator JAN 2021 - June 20231. Highly proficient in managing both project management and people management to provide input to the study team performing all clinical trial related activities from study initiation to close out of the study.2. Have Successfully coordinated, oversee and completed functions on assigned clinical trial activities such as Meeting Minutes, File reviews, Generating study and etal reports, preparing and maintaining the study team list, Tracking of project specific requirements, Systems access management for Organization/vendor/client in TMF and appropriate databases. Develop sufficient service/ program / product / diagnosis expertise to communicate directly with clinicians, staff, other departments, consultants, etc.3. Assisted in tracking and reporting Serious Adverse Events. Have liaised with physicians and leadership to develop and implement clinical trials and research programs and Worked closely with physicians and staff to facilitate research and enrollment to clinical trials.4. Having sound knowledge on handling end to end clinical trial activities such as clinical documents filing, documents tracking, performing timely quality checks, File reviews, metadata modifications using VEEVA ETMF, SHAREPOINT and CTMS databases.5. Successfully assisted with training and Onboarding of new CTC-Cs and acting as a mentor for the new joiners.6. Familiar with RAVE to perform the CDM activities such as discrepancy management, query resolution and manual review. Reviewed study protocol, eCRF completion guideline, Data Management plan, Statistical analysis plan and utilized these documents in performing data management activities.7.Liaised with monitors and investigative sites to resolve outstanding regulatory issues identified through ongoing regulatory review and investigator file reviews in a timely manner. Clinical Pharmacy intern (20••••20)• Dispensed drugs in hospital pharmacy and provided exceptional care to patients. • Detected, monitored, assessed and reported ADR’s.• Provided drug information services.• Counseled patients on the proper use of prescribed medications.
Experience
Foreign Pharmacy Grad - International Intern
May 2025 — Present · CA, US
Education
Bapuji College of Pharmacy
Doctor of Pharmacy - PharmD, Pharmacy
2014 — 2020
International Indian School, Dammam
12th , Science
2013 — 2014
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