Join Navitas Life Sciences, a leading global clinical research organization (CRO), as a Senior Clinical Research Associate (SCRA). Contribute to innovative clinical trials and accelerate life-saving therapies in a technology-driven environment.
About Navitas Life Sciences
Headquartered in Princeton, NJ, Navitas Life Sciences is a technology-backed CRO with over 1,000 employees across five countries. We provide end-to-end clinical trial services, regulatory support, and data solutions to biopharmaceutical clients. Learn more at Navitas Life Sciences.
Position Overview
The Senior Clinical Research Associate will oversee clinical trial activities, ensuring compliance with ICH E6 principles and local regulations. This role involves project setup, site monitoring, and stakeholder communication to drive trial success.
Key Responsibilities
Project Setup
- Conduct feasibility assessments and site selection activities.
- Negotiate and facilitate investigator/site contract execution.
- Develop and adapt study-specific documentation.
- Set up and maintain the Trial Master File (TMF).
- Support regulatory submissions.
Project Conduct
- Conduct site initiation and monitoring visits.
- Maintain communication with study teams, clients, and vendors.
- Resolve site-level issues, escalating to Project Manager (PM) as needed.
- Support PM with project updates and participate in client meetings.
- Manage CRF retrieval and query resolution.
Project Closeout
- Conduct site closeout visits.
- Ensure TMF completeness and compliance.
Qualifications
| Requirement | Details |
|---|---|
| Experience | Minimum 3 years of clinical monitoring experience |
| Education | Bachelor’s degree in life sciences, pharmacy, or related field preferred |
| Skills | Strong knowledge of GCP principles and local regulations |
| Travel | Willingness to travel as required for site visits |
Desirable Skills
- Proficiency in ICH E6 guidelines and SOPs.
- Experience with TMF management and regulatory submissions.
- Strong communication and problem-solving skills.
- Familiarity with clinical trial software (e.g., EDC systems).
Why Join Navitas Life Sciences?
Navitas fosters innovation and collaboration, offering opportunities to work on global trials, including virtual and infectious disease studies. Our flexible, technology-driven approach ensures efficient trial management.
Benefits
- Global Exposure: Work with international biopharma clients.
- Career Growth: Access training in advanced clinical research tools.
- Innovative Environment: Leverage platforms like pharmaREADY.
- Work-Life Balance: Rated 3.3/5 for balance by employees.
How to Apply
Apply through Navitas Life Sciences Careers or Indeed. Submit your resume and cover letter highlighting your monitoring experience and GCP knowledge.
Application Tips
- Tailor your resume to emphasize clinical trial experience.
- Prepare examples of site issue resolution for interviews.
- Research industry trends at Clinical Leader.
Verified by Trusted HRs
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Work Environment
- Location: Flexible, with site visits in assigned regions.
- Travel: Regular travel for monitoring visits.
- Setting: Hybrid model available (49% hybrid per reviews).
Equal Opportunity Employer
Navitas Life Sciences is committed to diversity and inclusion, ensuring equal opportunities for all candidates.
Take the Next Step
Join Navitas Life Sciences as a Senior Clinical Research Associate and shape the future of clinical research. Apply today to drive better outcomes in global trials!
