Dr. Sinchana Bojamma P K
Bangalore
Summary
Dynamic Clinical Research Professional with 2.5 years of extensive experience and proven expertise in clinical trial operations across diverse therapeutic areas. Adept at In-house documentation, On-site and remote monitoring and review, regulatory documentation, trial coordination, and team collaboration. Proven skills in ICH-GCP, NDCT, and eTMF systems, with a commitment to regulatory compliance and clinical data integrity.
Overview
2
2
years of professional experience
Work History
Clinical Research Associate Trainee
Invitro Research Solutions Pvt. Ltd
08.2025 - Current
- Conducting on-site monitoring, co-monitoring, remote monitoring visits.
- ICD, CRF review, IP, study supply accountability, adverse event review, SDR, SDV.
- Reviewing TMF/ISF and other study specific documents
- Handling of PD/PV, Closing DCF, Handling of CAPA.
- Preparing study documentation and assisting the Clinical Quality Assurance Manager/ regulatory authorities during audits/ inspections in- house or on site
- Providing training sessions on Standard Operating Procedure, GCP, regulatory requirements, protocol, IP management
- Prepare study specific checklists and KPIs.
- Preparing organizational SOP’s and providing training on the same.
- Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
- Preparing visit reports (SSV, SIV, SMV, SCV), filing, and collecting trial documents
- Performing QC review and maintenance of trial related documents and files
- Acting as a liaison with cross-functional team members to ensure timely completion of deliverables
Clinical Trial Assistant
Invitro Research Solutions Pvt. Ltd
08.2023 - 07.2025
- Assists Clinical Project Managers, CRA’s in maintaining, reviewing, and communicating project progress and clinical systems
- Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation.
- Preparing and reviewing TMF/ISF and other study specific documents for accuracy and completeness.
Education
Doctor of Pharmacy (Pharm-D) -
Rajiv Gandhi University of Health Sciences
01.2023
Skills
- CTMS- Octalsoft
- ETMF- KnowledgeNet
- EDC- BizNet, Clinevo
- Veeva Vault, Oracle
- Medidata Rave, IWRS
- Microsoft applications
- Risk based Monitoring (RBM)
- Clinical Trial Monitoring (On-site & Remote)
- Regulatory Submissions (CTRI, EC Dossiers)
- ICH-GCP, NDCT Rules, 21 CFR Part 11
- Project Coordination & Reporting
- Vendor & Site Management
- Training & Mentoring Site Team
- Project Coordination & Reporting
- Vendor & Site Management
- Training & Mentoring Site Team
Accomplishments
- Recognized as the Best Employee of the Month (May 2024).
- Honored with the Quarterly Reward and Recognition (July–Sep 2024).
- Certified and authorized Trainer at IVRS (Oct 2024)
- Authored 5 organization SOPs.
Affiliations
Registered Pharmacist | Karnataka State Pharmacy Council | Reg. No. 86873
Languages
English
Hindi
Kannada
Telugu
Malayalam
Kodava
Timeline
Clinical Research Associate Trainee
Invitro Research Solutions Pvt. Ltd
08.2025 - Current
Clinical Trial Assistant
Invitro Research Solutions Pvt. Ltd
08.2023 - 07.2025
Doctor of Pharmacy (Pharm-D) -
Rajiv Gandhi University of Health Sciences
Disclaimer
I hereby declare that the above furnished information is true to the best of my knowledge.
Internships
- Clinical Development Intern, Invitro Research Solutions Pvt. Ltd, Apr 2023 - Jul 2023
- Clinical Pharmacist Intern, S.S Institute of Medical sciences, Davangere, Jan 2022 - Jan 2023
- Research Intern, Climed Research Solution, Jun 2021 - Nov 2021
Publications
- Authored and published a scientific blog on “Decentralized Clinical Trials” on the company's official website. https://ivrs.org.in/blog/ivrs/ (Dec 2024)
- High perceived stress and its impact on anxiety, depression and quality of life in patients with chronic disease. European Journal of Pharmaceutical and Medical Research. 2023;10(9), 651-657
- Rifampicin- Amlodipine Interaction: A case report of Hypertension exacerbation. Journal of Pharmacovigilance and drug research. Jan-Mar 2023;4(1):29-31.
- Premenstrual Syndrome: Prevalence, Prognosticators, and impact on women's functional status. Journal of Xi'an Shiyou University, Natural Science Edition. Jul2022;18(7):418-430