Entry-Level Opportunity at Fortrea | Site Readiness and Regulatory Specialist

Entry-Level Opportunity at Fortrea | Site Readiness and Regulatory Specialist

Fortrea, a global contract research organization (CRO), is offering an exciting entry-level opportunity for those passionate about clinical research and regulatory compliance. As a Site Readiness and Regulatory Specialist 1, you will play a key role in transforming drug and device development while working in Bengaluru, Karnataka.

About Fortrea

With over 19,000 employees and operations in more than 90 countries, Fortrea is a leader in clinical research, offering cutting-edge solutions across 20 therapeutic areas. Fortrea is dedicated to advancing life-saving treatments by supporting pharmaceutical, biotechnology, and medical device industries with innovative patient access and clinical development services. This position will contribute directly to the success of the company’s regulatory and clinical operations.

Key Responsibilities

As a Site Readiness and Regulatory Specialist, your responsibilities include:

• Responsible for adherence to standard operating procedures (SOPs)
• Maintain and contribute to contracts tracking and status systems, and support maintenance of paper and electronic file systems.
• With regular guidance from line management and department colleagues, perform limited processing and maintenance of agreements which the department must deliver.
• Coordinate with clinical study teams regarding details and timelines for contracting, as well as contract status reporting.
• 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.
• Participate in discussions with department colleagues to improve departmental processes and procedures.
• Monitor assigned studies for compliance with internal processes and procedures, or otherwise according to specified Sponsor requirements.
• Identify problems or issues with departmental processes and procedures and escalate to Manager, Site Agreements.
• Review amendments including clinical study documents, Protocol, ICF amendments etc and negotiate with site and sponsor to finalize the contracts.
• Perform other duties as required by the Department.

Qualifications

To be eligible for this role, candidates must meet the following qualifications:

• Education: A bachelor’s degree in life sciences, regulatory affairs, or a related field is preferred.
• Skills: Familiarity with Standard Operating Procedures (SOPs) and strong organizational skills for tracking contracts and agreements.
• Experience: Entry-level candidates with a passion for clinical trials and regulatory affairs are encouraged to apply.

Location and Salary Details

This full-time, on-site position is based in Bengaluru East, Karnataka. The salary range is competitive, offering excellent growth opportunities within Fortrea’s global team.

How to Apply

Interested candidates should apply by visiting Fortrea’s career page.

Tagged as: Good Clinical Practice (GCP)