Job Title
Regulatory and Start-Up (Clinical Trial Contracts & Site Start-Up Specialist)
Company
(Fortrea – inferred from requisition context)
Location
Bangalore, Karnataka, India
Employment Type
Full-time
Job Posting
Posted today
Application deadline: July 31, 2026
Role Summary
This role focuses on clinical trial start-up activities and regulatory contracting, including managing Clinical Trial Agreements (CTAs), confidentiality agreements, amendments, and coordination between clinical, legal, regulatory, and sponsor teams to ensure timely study initiation and execution.
Key Responsibilities
Contract Management & Site Agreements
Draft, review, negotiate, and finalize:
Clinical Trial Agreements (CTAs)
Confidentiality Agreements (CDAs)
Amendments and related site documents
Coordinate with sponsors, legal, clinical operations, and study teams for contract execution
Track site contract timelines and ensure completion within study milestones
Maintain accurate contract status in systems (e.g., SAMS, UCV, and other trackers)
Manage approval workflows and obtain required authorizations
Ensure proper filing and documentation of executed contracts
Identify and escalate contracting risks or delays
Provide regular updates to stakeholders on contract progress
Protocol Amendment Management
Coordinate protocol amendment submissions and documentation updates
Support contract and budget revisions related to amendments
Communicate amendment requirements, timelines, and actions to sites and study teams
Track amendment progress from submission to implementation
Collaborate with Clinical Operations, Regulatory, Legal, and Finance teams
Ensure accurate documentation in tracking systems
Support site communication and query resolution to avoid delays
Compliance & Reporting
Ensure adherence to:
SOPs
Sponsor requirements
Quality standards
ICH-GCP guidelines
Maintain study trackers, metrics, and reports
Support audit readiness through proper documentation
Escalate risks and operational issues impacting study timelines
Participate in process improvement initiatives
Complete required training, compliance tasks, and timesheets
Required Skills & Competencies
Strong understanding of:
Clinical trial contracting
Protocol amendment processes
Clinical research operations
Knowledge of ICH-GCP guidelines
Excellent communication and negotiation skills
Strong stakeholder management abilities
High attention to detail and organizational skills
Ability to manage multiple studies under tight deadlines
Proficiency in contract tracking systems and MS Office
Educational Qualification
University/College degree (preferably Life Sciences)
OR allied health certifications (e.g., Nursing, Medical Lab Technology)
Equivalent experience may be considered
Experience Required
3–5 years in clinical research / related discipline
0–2 years in other professional roles acceptable
Work Environment
General office-based role
Requires coordination across multiple teams and systems
Key Role Focus (Simple View)
This job is mainly about:
Clinical trial contracts (CTAs)
Site start-up coordination
Protocol amendment handling
Cross-functional communication (Legal + Clinical + Regulatory + Finance)
Tracking systems and documentation compliance
Core Strengths Needed
Process-driven thinking
Strong coordination and communication
Detail-oriented documentation work
Ability to manage deadlines and stakeholders
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Basel | Zurich |Serbia :
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Budapest |BULGARIA :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
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Norway | NOrway |Romania :
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Brinny | Ringaskiddy |Carlow :
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Netherlands |Remote Australia :
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Australia | Renfrew | North York | Richmond Hill | Mississauga | Uxbridge |Canada :
Canada |Quebec :
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Brussels |Antwerp :
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Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
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Greece |North Island :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
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Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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South Africa | Midrand |Nišava District :
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Prague |Chile :
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