Fortrea Hiring Clinical Research Associate in Multiple Locations
About Company:
Fortrea is a leading global contract research organization (CRO) with decades of clinical development experience and scientific rigor. We provide a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 employees operating in more than 90 countries, Fortrea is committed to transforming drug and device development for partners and patients worldwide.
Position Name:
Clinical Research Associate
Organization:
Fortrea
Qualification:
- B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Life Sciences
Experience:
- 2 Years
Salary:
- ₹7.4 Lakhs per year
Location:
- Mumbai, India
- New Delhi, India
Summary of Responsibilities:
Responsibility | Description |
---|---|
Site Management | Manage clinical study sites in accordance with Fortrea’s SOPs, ICH GCP Guidelines, applicable project plans, and Sponsor requirements. |
Monitoring Responsibilities | Conduct pre-study, site initiation, process monitoring, routine monitoring, and close-out visits for clinical trials. |
Project Planning | Prepare and implement project plans related to clinical monitoring responsibilities. |
Subject Protection | Verify informed consent procedures and protocol requirements, ensuring compliance with regulatory requirements. |
Data Integrity | Conduct source document review, source document verification, and resolve queries following data review guidelines. |
Regulatory Compliance | Ensure site regulatory documents and eTMF/Sponsor documents are complete and current throughout the trial duration. |
Investigational Product Management | Ensure accurate inventory and accountability of investigational products, maintaining secure storage as per protocol requirements. |
Quality Control | Adhere to global quality control and CRA performance metrics, ensuring audit readiness at the site level. |
Leadership | Act as the Lead CRA for assigned projects. |
Qualifications:
- Education: University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). Equivalent experience can be substituted as appropriate.
- Knowledge: Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
- Experience: Minimum of 2 years of clinical monitoring experience.
Why Join Fortrea?
Fortrea is seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.