Fortrea is hiring for a Regulatory and Start-Up position in Bangalore, India. This full-time clinical research opportunity is suitable for experienced professionals with a background in Life Sciences, Nursing, Medical Technology, Laboratory Technology, allied health, or related disciplines.

The position primarily focuses on Clinical Trial Agreements (CTAs), site contracts, protocol amendments, regulatory coordination, documentation, and study start-up activities. Candidates with 3–5 years of clinical research experience and strong knowledge of ICH-GCP guidelines are preferred.

Professionals looking for clinical trial start-up jobs in Bangalore, regulatory start-up jobs, CTA contract jobs, or clinical research jobs at Fortrea can review the eligibility criteria below and apply before the deadline.

Job Overview

Key Responsibilities

As part of the Fortrea Regulatory and Start-Up role, the selected professional will support clinical study contracting, protocol amendments, regulatory coordination, and study execution.

Key responsibilities include:

• Draft, review, negotiate, and finalize Clinical Trial Agreements (CTAs), confidentiality agreements, contract amendments, and related site documentation.
• Coordinate with sponsors, legal teams, clinical operations teams, and study teams for timely execution of contracts.
• Manage site agreement timelines and ensure contracting activities meet study milestones and turnaround requirements.
• Maintain accurate contract status and documentation within SAMS, UCV, and other applicable clinical systems.
• Coordinate internal approval workflows and obtain appropriate authorizations for contract execution.
• Track executed agreements and ensure documents are appropriately filed and maintained.
• Proactively identify contracting risks, bottlenecks, and delays and escalate issues when necessary.
• Provide study teams and management with regular contract status updates.
• Coordinate protocol amendment submissions and associated documentation for assigned studies and sites.
• Support contract and budget revisions arising from approved protocol amendments.
• Communicate amendment requirements, timelines, action items, and documentation needs to relevant stakeholders.
• Track protocol amendment submissions, approvals, and implementation activities.
• Collaborate with Clinical Operations, Regulatory, Legal, Finance, and other cross-functional teams.
• Follow up with sites to resolve outstanding queries and minimize implementation delays.
• Maintain study trackers, operational reports, documentation, and metrics.
• Support inspection and audit readiness by ensuring documentation is accurate and complete.
• Ensure activities comply with company SOPs, sponsor requirements, quality standards, applicable regulations, and ICH-GCP principles.
• Participate in process improvement initiatives and support departmental objectives.
• Complete required training, timesheets, and compliance activities within established timelines.

Qualification & Eligibility

Candidates applying for the Fortrea Regulatory and Start-Up job in Bangalore should meet the following minimum educational requirements:

• University or college degree, with Life Sciences preferred, OR
• Certification in an appropriate allied health profession from an accredited institution.

Relevant allied health qualifications may include:

• Nursing
• Medical Technology
• Laboratory Technology
• Life Sciences
• Other relevant healthcare or clinical research disciplines

Fortrea states that relevant and equivalent experience may be considered in lieu of educational requirements.

Experience Required

Candidates should have approximately 3–5 years of clinical research experience, including strong working knowledge of ICH-GCP guidelines and applicable clinical research regulations.

The job description specifies:

• 3–5 years of experience in the job discipline.
• 0–2 years of experience in other professional roles.

Therefore, this position is primarily targeted toward experienced clinical research professionals rather than fresh graduates.

Required Skills

Applicants should possess:

• Strong understanding of clinical trial contracting.
• Knowledge of Clinical Trial Agreements and site contracts.
• Understanding of protocol amendment processes.
• Working knowledge of ICH-GCP.
• Knowledge of clinical research operations.
• Contract negotiation skills.
• Strong stakeholder management abilities.
• Excellent written and verbal communication.
• Strong organizational and multitasking capabilities.
• High attention to detail.
• Ability to manage multiple studies and competing priorities.
• Experience with contract tracking systems.
• Proficiency with Microsoft Office applications.
• Ability to consistently deliver high-quality work.

Who Should Apply?

This Fortrea clinical research opportunity may be particularly relevant for professionals currently working in areas such as:

Clinical Trial Start-Up | Site Activation | Regulatory Start-Up | Clinical Trial Agreements | Site Contracts | Study Start-Up | Clinical Operations | Regulatory Operations | Contract Management

Professionals who already have hands-on experience with CTAs, site contracting, protocol amendments, ICH-GCP, clinical trial documentation, and cross-functional study coordination may be particularly well aligned with the position.

Why Consider This Opportunity?

This role offers exposure to several important components of global clinical trial execution, including regulatory start-up, clinical trial contracting, site management, protocol amendments, compliance, and cross-functional stakeholder coordination.

Potential career-development advantages include:

• Exposure to clinical trial contracting and negotiation.
• Experience working with multidisciplinary clinical research teams.
• Involvement in protocol amendment management.
• Development of regulatory and operational expertise.
• Experience working with clinical study tracking systems.
• Exposure to audit-readiness and quality-compliance activities.
• Opportunity to strengthen stakeholder and project-management capabilities.

Specific employee benefits and compensation should be confirmed directly with Fortrea during the recruitment process.

Estimated Salary

Fortrea has not provided a salary range in the supplied job posting.

For structured-data purposes, an estimated market range for an experienced Regulatory and Start-Up / clinical research professional in Bangalore may be approximately:

₹7,00,000 – ₹14,00,000 per year

Important: This is an editorial market estimate and not an officially disclosed Fortrea salary range. Actual compensation can vary significantly based on experience, grade, responsibilities, current compensation, and company policy.

How to Apply

Application Link