Rahul Sathe
Clinical Research Associate-II @ Nextvel Consulting LLP | Master’s in Biotechnology
- Role
- Cra - Ii at Novotech
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Rahul Sathe
Detail-oriented Clinical Research Professional with almost 2 years of experience managing…
Experience
Cra - Ii
May 2025 — Present · Bengaluru, IN
Conducting of on-site and remote monitoring visits across multiple therapeutic areas, ensuring compliance with GCP, protocol, and regulatory requirements- Working on 6+ projects spanning clinical operations, regulatory affairs, medical writing, and both drug and medical device trials- Skilled in preparing and submitting regulatory documents for clinical trials (CT) and medical devices (MD), including coordination with regulatory authorities- Oversaw end-to-end site management activities such as EC submissions, feasibility questionnaires (FQ), site initiation visits (SIV), interim monitoring visits (IMV)- Collaborated with cross-functional teams in protocol design, development of Investigator Brochure (IB), Informed Consent Form (ICF), and Case Report Forms (CRF) for client-sponsored studies- Ensured data accuracy, protocol adherence, and subject safety through consistent site communication and documentation review.
Education
Nagpur University
Bachelor's degree, Biotechnology
Mgm University Chhatrapati Sambhajinagar
Master's degree, Biotechnology
IICRM Nagpur
PG Diploma , Clinical research | Regulatory affairs | Pharmacovigilance
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