Site Readiness and Regulatory Specialist 1

4 months ago


Bangalore, India MUM Fortrea Development India Pvt Ltd Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

1. Responsible for adherence to standard operating procedures (SOPs)

2. Maintain and contribute to contracts tracking and status systems, and support maintenance of paper and electronic file systems.

3. With regular guidance from line management and department colleagues, perform limited processing and maintenance of agreements which the department must deliver.

4. Coordinate with clinical study teams regarding details and timelines for contracting, as well as contract status reporting.

5. Assist Contracts Specialists in populating, mailing, scanning and tracking of contracts to ensure delivery and following up on contracts as necessary to ensure their prompt return.

6. Participate in discussions with department colleagues to improve departmental processes and procedures.

7. Monitor assigned studies for compliance with internal processes and procedures, or otherwise according to specified Sponsor requirements.

8. Identify problems or issues with departmental processes and procedures and escalate to Manager, Site Agreements.

9. Review amendments including clinical study documents, Protocol, ICF amendments etc and negotiate with site and sponsor to finalize the contracts.

10. Perform other duties as required by the Department.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering 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.


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