Posted:Just now|
Platform:
Work from Office
Full Time
The Study Start-Up Clinical Research Associate (SSU CRA) plays a critical role in ensuring efficient and compliant trial start-up activities at clinical sites. This position is responsible for site selection, preparation, and activation for Phase I-IV clinical trials. SSU CRA acts as the primary liaison between the sponsor and the site during the start-up phase, ensuring all regulatory, ethical, and operational requirements are met to achieve site readiness. About the Role Key Responsibilities: Lead and execute site selection and start-up activities from country allocation to site greenlight. Serve as the main point of contact for trial sites during start-up, including IRB/IEC and Health Authority submission preparation. Ensure timely collection and submission of site-specific documents (e. g. , CVs, GCP certificates, financial disclosures). Support the preparation of country-specific documents and patient-facing materials. Coordinate vendor setup and assist with financial contract negotiations with investigational sites. Maintain accurate and up-to-date documentation in Trial Master File (TMF) and internal systems. Collaborate with internal stakeholders to ensure seamless handover to execution CRAs and readiness for audits and inspections. Essential Requirements: Bachelor s degree in a scientific or health discipline; clinical operations experience preferred. Minimum 3 years of experience in clinical operations, particularly in site management or monitoring. Strong knowledge of ICH/GCP guidelines, local regulatory requirements, and clinical trial processes. Excellent interpersonal, negotiation, and conflict resolution skills. Proven ability to manage multiple priorities and adapt to fast-changing environments. Willingness and ability to travel for site visits and meetings.
NOVARTIS
Upload Resume
Drag or click to upload
Your data is secure with us, protected by advanced encryption.
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.
We have sent an OTP to your contact. Please enter it below to verify.
Instantly access job listings, apply easily, and track applications.
6.0 - 10.0 Lacs P.A.
Mumbai Metropolitan Region
Salary: Not disclosed
Mumbai, Maharashtra
Salary: Not disclosed
Mumbai Metropolitan Region
Salary: Not disclosed
Bengaluru
2.0 - 5.0 Lacs P.A.
1.0 - 4.25 Lacs P.A.
Lucknow, Mathura, Moradabad
1.5 - 4.0 Lacs P.A.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
2.0 - 4.0 Lacs P.A.
Lucknow, Mathura, Meerut
Experience: Not specified
11.0 - 21.0 Lacs P.A.
6.0 - 10.0 Lacs P.A.
