Study Start-Up Clinical Research Associate
Study Start-Up Clinical Research Associate
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Job Description
Band
Level 3Job Description Summary
#LI-HybridLocation: Mumbai India
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 IIV 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.
Job Description
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:
Bachelors 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.
Commitment to Diversity and Inclusion / EEO paragraph:
Novartis is committed to building an outstanding inclusive work environment and diverse teams
representative of the patients and communities we serve.
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to perform the essential functions of a position please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Skills Desired
Clinical Monitoring Clinical Research Clinical Study Reports Clinical Trial Management Systems Clinical Trials Collaboration Data Integrity Decision Making Skills LifesciencesRequired Experience:
IC
Employment Type
Full-Time
