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Site Navigator Ii

Fortrea
Fortrea
1-2 years
Not Disclosed
Bangalore, India
10 April 8, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Site Navigator II

Location: Bangalore
Job Type: Full-Time
Application Deadline: April 30, 2026
Job Requisition ID: 261027

Job Overview
We are seeking a highly organized and detail-oriented Site Navigator II to support and coordinate site-level clinical trial activities throughout the start-up phase and, when required, through study closeout. This role serves as the primary point of contact for investigative sites and plays a vital role in ensuring seamless site activation, regulatory compliance, study documentation management, and operational readiness throughout the clinical research lifecycle.

The Site Navigator II will collaborate closely with sponsors, CRO teams, investigators, regulatory authorities, and clinical site staff to ensure successful execution of site start-up and maintenance activities in compliance with ICH/GCP guidelines and local regulations.

Experience Required

  • Minimum 2+ years of experience in clinical development, clinical trial start-up, or regulatory processes

  • Strong understanding of ICH/GCP guidelines, regulatory authority (RA), and IRB/IEC regulations

  • Experience with investigator start-up documents, site activation, and regulatory submissions

  • Familiarity with clinical trial contracts and budget negotiation processes

  • Previous experience interacting with project teams and investigative sites

  • Strong understanding of research protocols and site-level study requirements

Key Responsibilities

  • Coordinate and oversee site-level activities related to clinical trial start-up and activation

  • Ensure site activation is completed in accordance with ICH/GCP guidelines, SOPs, local regulations, and project timelines

  • Identify and assess potential research sites based on study requirements and capabilities

  • Conduct initial site outreach, feasibility assessments, confidentiality agreements, and engagement activities

  • Perform remote pre-study visits and complete associated documentation including trip reports and visit preparation

  • Support informed consent form customization and translation of patient-facing materials

  • Collect, review, and track essential regulatory and activation documents through the site activation process

  • Monitor site regulatory compliance including renewals, PI changes, and document expirations

  • Participate in team meetings and contribute to action plans for site risks or underperformance

  • Support CRA teams with Site Initiation Visit (SIV) preparation and study supply coordination

  • Liaise with IRB/IEC, regulatory authorities, and third parties for submissions and approvals

  • Conduct contract and budget negotiations with research sites, including amendments where applicable

  • Ensure Trial Master File (TMF) is updated, compliant, and audit-ready

  • Track progress of the site start-up process to ensure milestones and deadlines are achieved

  • Serve as the primary contact for investigative sites and provide timely support throughout study execution

  • Perform remote monitoring visits, source data verification (SDV), and source data review (SDR) when required

  • Conduct CRF review and data validation against source documents

  • Monitor protocol deviations, SAE reporting, and study compliance requirements

  • Review and customize country/site informed consent forms based on local requirements

Required Qualifications

  • Bachelor’s degree in Life Sciences preferred, or certification in allied health profession such as nursing, medical technology, or laboratory science

  • Equivalent relevant experience may be considered in lieu of formal education

  • Candidates with High School Diploma and 5+ years of clinical research experience may also be considered

  • Fluency in English and local language, both written and verbal

Preferred Skills

  • Excellent communication and stakeholder management skills

  • Strong organizational and multitasking abilities

  • Ability to manage multiple deadlines in a fast-paced clinical environment

  • Strong negotiation and problem-solving capabilities

  • Attention to detail and regulatory compliance mindset

Work Environment

  • Primarily remote-based with occasional office presence depending on location

  • Limited travel required for training purposes

Why Join This Opportunity
This role offers a valuable opportunity for professionals looking to grow their career in clinical operations, site activation, regulatory affairs, and clinical trial management while contributing to successful study execution in a dynamic and globally collaborative environment.

Apply now to advance your career in clinical research and site management.