Novotech is a leading global Contract Research Organization (CRO) specializing in clinical trials across Asia-Pacific, North America, and Europe. With 3,000+ employees and 5,000+ site partnerships, Novotech accelerates drug development for biotech companies.
Key Highlights:
✔ ISO 27001 & 9001 Certified – Ensuring high IT security and quality standards.
✔ Full-service CRO – End-to-end clinical trial management.
✔ Inclusive workplace – Supports LGBTIQ+, disability, and caregiver-friendly policies.
Job Title: In-House Clinical Research Associate (IHCRA)
Location: India
Experience Level: Entry to 2 years
Job Type: Full-time
Job Description
The In-House CRA (IHCRA) supports clinical teams in document management, regulatory compliance, and trial coordination following ICH-GCP guidelines and Novotech/client SOPs.
Key Responsibilities:
✔ Trial Master File (TMF) Management – Track, QC, and reconcile study documents.
✔ Regulatory & Compliance Support – Assist in IRB submissions, safety reporting (SUSAR, DSUR), and CSR submissions.
✔ Clinical Trial Management System (CTMS) Maintenance – Ensure site compliance tracking, subject enrollment updates, and milestone management.
✔ Investigator Site File (ISF) Coordination – Manage trial supplies (lab kits, patient diaries, drug logistics).
✔ Remote Monitoring Support – Assist CRAs with site visit preparations and follow-ups.
Eligibility & Qualifications:
✅ Bachelor’s degree in Life Sciences, Pharmacy, or related fields.
✅ 0–2 years of experience in CROs, pharma, or healthcare (preferred).
✅ Familiarity with ICH-GCP, TMF, CTMS, and regulatory submissions.
✅ Strong organizational & communication skills.
Benefits at Novotech:
🌟 Flexible Work Options – Hybrid/remote opportunities.
🌟 Paid Parental Leave – For both parents.
🌟 Wellness Programs – Mental health & fitness support.
🌟 Career Growth – Training & global project exposure.
🌟 Inclusive Culture – LGBTIQ+, disability, and caregiver-friendly policies.
How to Apply
