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🇮🇳 India – Remote

⏰ Full Time

🟢 Junior

✨ Navigator

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Coordinate site-level activities throughout clinical study start-up and potentially closeout • Serve as the primary point of contact for investigative sites • Identify and assess potential research sites • Conduct initial site outreach and collect confidentiality agreements and feasibility surveys • Manage site-level activities, resolve issues, and support study timelines and compliance • Conduct remote pre-study visits and complete follow-up documentation • Support customization and translation of informed consent forms and patient-facing materials • Collect, track, and quality-review essential documents for site activation and ongoing regulatory compliance • Support IRB/IEC renewals, PI changes, and document expiration management • Participate in study team meetings and develop action plans for site-level risks and issues • Support CRA teams in preparing site initiation visits and coordinating supplies, access, and documents • Submit to and liaise with IRB/IEC, third bodies, and regulatory authorities • Conduct initial and amended contract and budget negotiations with sites • Maintain filing quality in applicable systems and keep the Trial Master File audit ready • Track start-up progress and ensure sites meet requirements and deadlines • Maintain Fortrea system compliance and audit readiness • Ensure timely delivery to investigative sites within scope and budget • Perform CRF review, source data validation, and monitoring of protocol deviations and SAE reporting • Perform country and site informed consent form review and customization • Perform other assigned duties

🎯 Requirements

• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution, or 2–3 years' work experience in clinical research • Relevant and equivalent experience may be considered in lieu of educational requirements • High School Diploma or equivalent plus a minimum of 5 years' work experience in clinical research may be considered • Working knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations • Fluent in the local official language and English, written and verbal • At least one year of experience in a related field • Basic knowledge of ICH/GCP, RA, IRB/IEC, and applicable regulations/guidelines • Familiarity with investigator start-up documents and contract/budget negotiation processes • Understanding of research protocol requirements • Ability to manage multiple tasks and deadlines simultaneously • Understanding of clinical trial and research regulations and guidelines • Ability to identify and resolve issues during the start-up process • Ability to negotiate contracts and budgets effectively with research sites

🏖️ Benefits

• Remote-based work • Limited travel, restricted to training only • Possible office presence depending on location • EEO and accommodations support