Fortrea, a leading global contract research organization (CRO), is currently hiring experienced professionals for the Regulatory and Start-Up role in Bangalore, India. Candidates with 3-5 years of clinical research experience and strong knowledge of clinical trial agreements, protocol amendments, and ICH-GCP guidelines are encouraged to apply.

This is an excellent opportunity for clinical research professionals looking to advance their careers in regulatory affairs, site start-up activities, contract management, and clinical trial operations within a globally recognized CRO.

Job Overview

Key Responsibilities

Clinical Trial Contract Management

• Draft, review, negotiate, and finalize Clinical Trial Agreements (CTAs).
• Prepare confidentiality agreements, amendments, and related site contracts.
• Coordinate with sponsors, legal teams, clinical operations, and study teams.
• Ensure timely contract execution according to study milestones.
• Manage contract approval workflows and obtain required authorizations.
• Track contract status and maintain documentation in applicable systems.
• Identify contracting risks and escalate issues when necessary.

Protocol Amendment Management

• Coordinate protocol amendment submissions for assigned studies.
• Support amendment-related contract and budget revisions.
• Communicate amendment requirements and timelines to study teams.
• Track amendment progress and ensure timely approvals.
• Collaborate with Regulatory, Legal, Clinical Operations, and Finance teams.
• Maintain accurate amendment documentation and study trackers.

Compliance & Quality Support

• Ensure adherence to SOPs, sponsor requirements, and ICH-GCP guidelines.
• Maintain audit-ready documentation.
• Support process improvement initiatives.
• Deliver accurate reports, metrics, and status updates.
• Complete assigned compliance and training activities within timelines.

Required Qualifications

Candidates should possess:

• Bachelor’s or Master’s Degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, Microbiology, Biochemistry, or related fields.
• Nursing, Medical Technology, or Laboratory Technology certifications may also be considered.
• Strong understanding of clinical trial contracting and regulatory processes.
• Knowledge of ICH-GCP guidelines and global clinical research regulations.
• Excellent communication and stakeholder management skills.
• Ability to manage multiple projects simultaneously.

Experience Required

• Minimum 3-5 years of experience in clinical research.
• Experience in clinical trial agreements (CTAs), site contracts, or regulatory start-up activities.
• Working knowledge of protocol amendment management.
• Experience interacting with sponsors, sites, legal, and finance teams.

Preferred Skills

• Clinical Trial Agreements (CTA)
• Site Start-Up Activities
• Regulatory Affairs
• Protocol Amendments
• Contract Negotiation
• Clinical Operations
• ICH-GCP Compliance
• Clinical Research Documentation
• Stakeholder Management
• Microsoft Office Suite

Why Join Fortrea?

Fortrea is recognized globally for delivering clinical development solutions across therapeutic areas. Employees benefit from:

• Global clinical research exposure
• Career advancement opportunities
• Cross-functional collaboration
• International project experience
• Competitive compensation packages
• Professional development programs
• Flexible and inclusive work culture

Who Should Apply?

This opportunity is ideal for:

• Clinical Research Associates (CRAs)
• Site Start-Up Specialists
• Regulatory Affairs Associates
• Clinical Trial Coordinators
• Contract Specialists
• TMF Professionals seeking transition into start-up activities
• Life Sciences graduates with relevant CRO experience

How to Apply

Application Link