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Company: Fortrea
Job Title: Regulatory and Start-Up
Location: Bengaluru, Karnataka, India
Experience: 3–5 Years
Qualification: University/ College Degree, preferably in Life Sciences, or an accredited allied health profession certification
Industry: Clinical Research / Clinical Trials
Job Description
Fortrea is inviting applications for the Regulatory and Start-Up position in Bengaluru, Karnataka. This opportunity is suitable for professionals with 3–5 years of experience in clinical research, clinical trial contracting, and protocol amendment management.
The selected candidate will coordinate clinical trial agreements, support protocol amendments, collaborate with cross-functional teams, and ensure compliance with applicable regulations, sponsor requirements, and ICH-GCP guidelines.
Key Responsibilities
- Draft, review, negotiate, and finalize Clinical Trial Agreements (CTAs), confidentiality agreements, amendments, and related documentation.
- Coordinate with sponsors, legal teams, Clinical Operations, Regulatory, and study teams to facilitate timely contract execution.
- Monitor contract timelines and ensure completion within agreed study milestones.
- Maintain contract status updates, study trackers, and documentation in applicable systems.
- Coordinate protocol amendment submissions and associated contract and budget revisions.
- Communicate amendment requirements, timelines, and outstanding actions to sites and study teams.
- Track approvals, executed agreements, and amendment implementation activities.
- Identify contracting risks, delays, and operational challenges and escalate them when required.
- Ensure compliance with SOPs, sponsor requirements, quality standards, and ICH-GCP principles.
- Support audit readiness, reporting, process improvement, and departmental objectives.
Required Skills and Competencies
- Understanding of clinical trial contracting and protocol amendment processes.
- Knowledge of ICH-GCP guidelines and clinical research operations.
- Strong communication, negotiation, and stakeholder management skills.
- Excellent organizational skills and attention to detail.
- Ability to manage multiple studies and competing priorities.
- Proficiency in Microsoft Office and contract tracking systems.
- Ability to collaborate effectively with internal and external stakeholders.
Eligibility Criteria
Educational Qualification: A university or college degree, preferably in Life Sciences, or certification in an allied health profession from an accredited institution. Relevant equivalent experience may be considered.
Work Experience: 3–5 years of experience in the relevant job discipline, with clinical research experience and a strong working knowledge of ICH-GCP guidelines and applicable regulations.
Candidates should demonstrate effective communication, teamwork, accuracy, and the ability to deliver high-quality work within established timelines.
How to Apply
Interested and eligible candidates can review the complete job description and submit their applications through the official job listing.
Apply Online: Fortrea – Regulatory and Start-Up Job
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