Fortrea is hiring for the Site Navigator position across Bangalore, Hyderabad, Pune, and Mumbai. The role focuses on coordinating clinical study site activities from feasibility and initial outreach through site activation and, where required, closeout activities.

The Site Navigator serves as the primary contact for investigative sites and supports regulatory compliance, site management, site support, training, documentation, and collaboration between sponsors, CROs, and clinical site staff.

Job Details

Position

Site Navigator

The Site Navigator coordinates site-level activities during the clinical study start-up phase and may support activities through study closeout. The position involves site selection, outreach, activation, regulatory documentation, contract and budget negotiations, and ongoing site support.

Responsibilities

• Coordinate site-level activities for efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs, and project requirements.
• Identify potential research sites and assess their capabilities and resources.
• Conduct initial site outreach and collect Confidentiality Agreements and feasibility surveys.
• Conduct remote Pre-Study Visits and complete required follow-up documentation.
• Collect, track, and quality-review essential documents required for site activation.
• Support regulatory compliance, including annual IRB/IEC renewals, PI changes, and document expirations.
• Participate in study team meetings and develop action plans for site-level risks and issues.
• Support CRA teams in preparation for Site Initiation Visits (SIVs).
• Coordinate with vendors, supply teams, and study leads for clinical study supplies, access, and documents.
• Submit to and liaise with applicable IRB/IEC, Third Bodies, and Regulatory Authorities.
• Perform initial and amended contract and budget negotiations with research sites.
• Maintain high-quality documentation and ensure the Trial Master File (TMF) remains audit ready.
• Track the start-up process and site requirements and deadlines.
• Serve as the primary contact for investigative sites.
• Perform CRF review and data validation against source documentation, where applicable.
• Monitor site protocol deviations and Serious Adverse Event (SAE) reporting.
• Perform country and site Informed Consent Form (ICF) review and customization according to local requirements.
• Support customization and translation of informed consent forms and patient-facing materials.

Eligibility / Qualifications

• University/College degree, preferably in Life Sciences, or certification in a related allied health profession.
• Relevant certifications may include nursing, medical technology, or laboratory technology.
• 2–3 years of clinical research work experience may be considered with working knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations.
• Relevant and equivalent experience may be considered in lieu of educational requirements.
• Candidates with a High School Diploma or equivalent and at least 5 years of clinical research experience may also be considered, provided they have strong knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations.
• Fluency in the local official language and English, both written and verbal.

Required Skills and Experience

• Scientific degree and/or clinical expertise is optimal.
• At least 1 year of experience in a related field, such as medical, clinical, pharmaceutical, laboratory research, data analysis, data management, or technical writing.
• One year of clinical research experience is preferred.
• Basic knowledge of ICH/GCP, RA, IRB/IEC, and applicable regulations and guidelines.
• Familiarity with investigator start-up documents.
• Familiarity with contract and budget negotiation processes.
• Understanding of research protocol requirements.
• Experience interacting with operational project teams and investigative sites is preferred.
• Effective communication with site staff, CRO personnel, and regulatory authorities.
• Ability to manage multiple tasks and deadlines simultaneously.
• Ability to identify and resolve issues during the study start-up process.
• Ability to negotiate contracts and budgets with research sites.
• Understanding of clinical trial regulations and guidelines.

Work Environment

The role is remote-based, with possible office presence depending on location. Travel requirements are limited to training only.

Application Details

Application Link