Fortrea is hiring for the position of Start-up Associate in Bangalore. The role involves working with investigative sites during study maintenance and, when assigned, site startup activities. The position focuses on collecting investigator and regulatory essential documents, supporting regulatory submissions, tracking site activation activities, and maintaining study documentation in compliance with applicable requirements.

Job Details

Position: Start-up Associate

The Start-up Associate serves as a primary contact for investigative sites and supports site startup and maintenance activities. The role includes collecting and reviewing essential documents, supporting IRB/IEC/Third body/Regulatory Authority submissions, updating study systems, and ensuring assigned activities remain on track.

Responsibilities

• Develop awareness of regulatory legislation, guidance, and practices in assigned countries with support from senior staff.
• Assist with compiling, preparing, submitting, and obtaining approval for submission documents to IRB/IEC/Third body/Regulatory Authority.
• Liaise with internal and external vendors for Regulatory Authority submissions, where applicable.
• Review final submission documents as applicable.
• Organize communication related to submissions and outcomes within Fortrea.
• Escalate study issues appropriately and in a timely manner.
• Serve as the primary contact for investigative sites.
• Collect and track documents required for site activation and maintenance.
• Perform quality review, formatting, and compilation of final documents.
• Ensure assigned maintenance and startup activities are on track and aligned with client expectations, ICH/GCP, SOPs, budget, quality requirements, and applicable laws and guidelines.
• Update study documents following changes in study personnel or study amendments.
• Ensure high-quality documents are filed and study systems are updated on an ongoing and timely basis.
• Update status reports, applicable logs, and tracking systems with input from senior staff.
• Adapt Informed Consent Forms and other patient-facing materials to country-specific requirements under guidance.
• Support the contract negotiation process under supervision, where applicable.
• Identify and escalate risks to meeting deliverables.
• Notify the Submissions Lead of hours identified as out-of-scope or over burn with support from senior specialists.
• Upload submission documentation to Clinical Trials Information System (CTIS) under supervision, where applicable for the centralized EU role.

Eligibility & Qualifications

Candidates should have:

• A university or college degree, preferably in Life Sciences.
• Certification in a related allied health profession from an appropriate accredited institution may also be considered, including nursing, medical technology, or laboratory technology.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• 0–2+ years of experience, or an equivalent combination of education and experience.
• Working knowledge of ICH, Regulatory Authority (RA), IRB/IEC, and other applicable regulations and guidelines.
• Basic understanding of the clinical trial process.

Required Skills

• Basic understanding of clinical trial processes.
• Working knowledge of ICH/GCP and applicable regulations and guidelines.
• Regulatory submission support.
• Investigative site communication and document collection.
• Document quality review, formatting, and compilation.
• Study document and tracking-system management.
• Awareness of regulatory requirements in assigned countries.
• Ability to identify and escalate study issues and delivery risks.

Application Details

Position: Start-up Associate
Location: Bangalore
Job Type: Full Time
Experience: 0–2+ years
Application Deadline: October 31, 2026
Job Requisition ID: 265209

Application Link