Fortrea Recruitment – Site Navigator I

Fortrea is hiring a Site Navigator I for its clinical research operations in India. This full-time opportunity is available to candidates based in Bangalore, Hyderabad, Pune, Mumbai, and other locations across India through a remote working arrangement. The role focuses on clinical trial site start-up, feasibility assessments, regulatory submissions, essential document management, and site activation. Candidates with a relevant degree or equivalent experience, knowledge of ICH-GCP guidelines, and experience in clinical research or related fields can apply.

Company Overview

Fortrea is a global clinical research services company supporting pharmaceutical and biotechnology organizations in clinical development. The Site Navigator I role helps coordinate investigative site activities, maintain regulatory compliance, and support the timely initiation and management of clinical studies.

Job Details

Job Role & Responsibilities

The Site Navigator I will coordinate clinical trial site activities from feasibility and initial outreach through site activation and, when required, study closeout. The role serves as a primary point of contact for investigative sites and supports collaboration between sponsors, CRO teams, and site staff.

Key responsibilities include:

• Coordinate site-level tasks for efficient site activation in compliance with ICH-GCP guidelines, local regulations, SOPs, and project requirements.

• Identify potential research sites and assess their capabilities, resources, and suitability for clinical studies.

• Conduct initial site outreach, obtain confidentiality agreements, and collect feasibility surveys.

• Perform remote pre-study visits, prepare visit documentation, and complete trip reports.

• Support customization and translation of informed consent forms (ICFs) and patient-facing materials.

• Collect, track, and quality-check essential documents required for site selection, regulatory submissions, and site activation.

• Monitor site regulatory compliance, including applicable ethics committee renewals, principal investigator changes, and document expirations.

• Participate in study team meetings and develop action plans for site-level risks, delays, and performance issues.

• Support Clinical Research Associate (CRA) teams in preparing for Site Initiation Visits (SIVs).

• Coordinate clinical study supplies, access requirements, and documentation with vendors and study teams.

• Prepare submissions to and liaise with Institutional Review Boards (IRBs), Independent Ethics Committees (IECs), third bodies where applicable, and regulatory authorities.

• Collaborate with Global Regulatory Submissions Leads on regulatory submissions.

• Conduct initial site contract and budget negotiations, including amendments where applicable.

• Maintain accurate essential documents and keep the Trial Master File (TMF) audit-ready.

• Track site start-up progress and ensure that milestones and deadlines are met.

• Serve as the primary contact for investigative sites and support timely delivery within the study scope and budget.

• Perform Case Report Form (CRF) reviews and validate clinical data against source documentation, as applicable.

• Support monitoring of protocol deviations, Serious Adverse Event (SAE) reporting, and other study activities as assigned.

Eligibility & Qualifications

Candidates should meet one of the qualification pathways specified by Fortrea:

• University or college degree, preferably in Life Sciences.

• Certification in a related allied health profession from an accredited institution, such as nursing, medical technology, or laboratory technology.

• Alternatively, 2–3 years of work experience in clinical research, including working knowledge of ICH-GCP guidelines and regulatory authority and IRB/IEC regulations.

• Fortrea may consider relevant equivalent experience instead of the stated educational requirements.

• Candidates with a high school diploma or equivalent and at least 5 years of clinical research experience, including strong knowledge of ICH-GCP and regulatory and IRB/IEC requirements, may also be considered under the alternative pathway.

Candidates must be fluent in the relevant local official language and English, both written and spoken.

Experience Requirements

Fortrea identifies the following experience and knowledge as important for this role:

• At least one year of experience in a related field, such as medical, clinical, pharmaceutical, or laboratory research, data analysis, data management, or technical writing.

• One year of clinical research experience is preferred.

• Basic knowledge of ICH-GCP, regulatory authority requirements, IRB/IEC regulations, and applicable clinical research guidelines.

• Familiarity with investigator site start-up documents and contract and budget negotiations.

• Understanding of clinical research protocols and study requirements.

• Experience interacting with operational project teams and investigative sites is preferred.

Required Skills & Competencies

Applicants should demonstrate:

• Strong written and verbal communication skills.

• Ability to coordinate with site staff, CRO personnel, sponsors, and regulatory authorities.

• Effective organization and time management.

• Ability to manage multiple tasks, competing priorities, and deadlines.

• Understanding of clinical trial regulations and compliance requirements.

• Problem-solving skills to identify and resolve site start-up issues.

• Ability to support site contract and budget negotiations.

• Attention to detail in regulatory documentation and Trial Master File maintenance.

Work Location & Environment

The position is remote-based in India, with possible office presence depending on the candidate’s location. Travel requirements are limited to training, according to the job description.

Listed locations include:

• Bangalore, Karnataka

• Hyderabad, Telangana

• Pune, Maharashtra

• Mumbai, Maharashtra

• Remote India

How to Apply

Interested candidates can review the complete job description and apply through Fortrea’s official careers portal.

Apply for Site Navigator I at Fortrea

Applicants should highlight relevant clinical research experience, ICH-GCP knowledge, regulatory documentation skills, site start-up experience, and familiarity with clinical trial workflows in their resumes.

Job Summary

Tagged as: Audit, Clinical Research, Documentation, Qualification, Regulatory Compliance, Regulatory Submissions, remote