Regulatory and Start-Up
Company: Fortrea
Job Location: Bangalore, India
Employment Type: Full-Time
Work Environment: General Office Environment
Job Requisition ID: 262931
Application Deadline: August 31, 2026
Job Overview
The Regulatory and Start-Up role is responsible for supporting clinical trial site contracting, regulatory start-up activities, protocol amendments, documentation, and study timelines.
The position involves close collaboration with Sponsors, Clinical Operations, Legal, Regulatory, Finance, study teams, and clinical trial sites to ensure contracts, amendments, approvals, and required documentation are completed accurately and within agreed timelines.
Key Responsibilities
Clinical Trial Contracting
Draft, review, negotiate, and finalize Clinical Trial Agreements (CTAs).
Manage confidentiality agreements, amendments, and related site contract documentation.
Coordinate with sponsors, Legal, Clinical Operations, and study teams for timely contract execution.
Track site agreement timelines against study milestones and agreed turnaround times.
Maintain accurate contract status and documentation in SAMS, UCV, and other applicable systems.
Facilitate internal approval workflows and obtain required authorizations.
Track contract execution and ensure finalized documents are properly filed.
Identify contracting risks, delays, and issues and escalate them appropriately.
Provide regular contract-status updates to study teams and management.
Protocol Amendment Management
Coordinate protocol amendment submissions and related documentation updates.
Support amendment-related contract and budget revisions following approved protocol changes.
Review amendment requirements and communicate action items and timelines to sites and study teams.
Track amendment progress through submission, approval, and implementation.
Coordinate with Clinical Operations, Regulatory, Legal, and Finance teams.
Ensure amendment documentation is accurately uploaded and maintained in relevant systems.
Follow up with sites regarding outstanding queries and documentation.
Help prevent delays in amendment implementation.
Compliance & Documentation
Ensure compliance with:
ICH-GCP
Company SOPs
Sponsor requirements
Applicable regulatory requirements
Quality standards
Maintain accurate study trackers, reports, and operational metrics.
Ensure documentation is complete and audit-ready.
Escalate risks, delays, and operational challenges that may affect study deliverables.
Stakeholder & Study Support
Collaborate with internal and external stakeholders to support efficient study execution.
Communicate effectively with sites, sponsors, study teams, and cross-functional departments.
Support process-improvement initiatives.
Contribute to departmental goals and objectives.
Complete required training, timesheets, and compliance activities within timelines.
Required Skills & Competencies
Strong understanding of clinical trial contracting.
Knowledge of protocol amendment processes.
Strong understanding of ICH-GCP guidelines.
Knowledge of clinical research operations.
Excellent communication and negotiation skills.
Strong stakeholder-management capabilities.
Excellent organizational and multitasking skills.
High attention to detail.
Ability to manage multiple studies and priorities simultaneously.
Ability to work effectively under tight timelines.
Experience with contract tracking systems.
Good knowledge of Microsoft Office applications.
Minimum Qualifications
University/College degree, preferably in Life Sciences.
Allied-health certification may also be considered, such as:
Nursing
Medical Technology
Laboratory Technology
3–5 years of experience in clinical research.
Strong working knowledge of ICH-GCP and applicable clinical research guidelines/regulations.
Fortrea may consider relevant equivalent professional experience in place of formal educational requirements.
Experience Required
3–5 years of experience in the relevant job discipline.
0–2 years of experience in other professional roles may be considered.
Demonstrated ability to organize and communicate effectively.
Strong attention to detail.
Ability to work effectively with cross-functional teams.
Ability to consistently deliver high-quality work.
Comfortable using computers, departmental systems, trackers, and other tools.
Core Skills
Clinical Research | Clinical Trial Agreements (CTA) | Site Contracting | Regulatory Start-Up | Protocol Amendments | ICH-GCP | Clinical Operations | Contract Negotiation | Stakeholder Management | Site Management | Documentation | Study Trackers | SAMS | UCV | Microsoft Office | Audit Readiness | Risk Escalation | Cross-functional Coordination
Experience – 1-Line Summary
3–5 years of clinical research experience with strong exposure to clinical trial contracting, CTAs, protocol amendments, ICH-GCP, regulatory/start-up activities, documentation, stakeholder coordination, and study tracking.
Salary Package – Market Estimate
The official Fortrea JD does not disclose a salary range. For a Bangalore-based Regulatory/Clinical Trial Start-Up role requiring around 3–5 years of experience, a reasonable market estimate is approximately ₹6–10 LPA CTC, with candidates having strong CTA negotiation, regulatory start-up, and sponsor-facing experience potentially targeting ₹8–12 LPA.
Expected market range: ₹6–10 LPA
Strong candidate range: ₹8–12 LPA
Note: This is a market estimate and not an officially confirmed Fortrea salary range.
Ideal Candidate Profile
The ideal candidate would have 3–5 years of clinical research experience with practical exposure to Clinical Trial Agreements, site contracting, protocol amendments, regulatory/start-up activities, ICH-GCP, study documentation, trackers, and cross-functional stakeholder management.
Experience working with Sponsors, CROs, Clinical Operations, Legal, Regulatory, Finance, and clinical sites would be particularly relevant.
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