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Site Navigator Ii

Fortrea
Fortrea
2+ years
Not Disclosed
Bangalore, India
10 April 22, 2026
Job Description
Job Type: Full Time Education: B.Pharm. or Post-Graduation (Microbiology/Quality Assurance/Biochemistry/Biotechnology) 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

Job Title:

Site Navigator II


Company:

Fortrea


Job Overview:

The Site Navigator II is responsible for coordinating site-level activities during clinical study start-up and activation, and may support activities through study maintenance and closeout. Acting as the primary point of contact for investigative sites, this role ensures regulatory compliance, efficient site activation, and strong collaboration between sponsors, CROs, and site staff. The role also serves as a local subject matter expert and may mentor junior team members.


Key Responsibilities:

Site Start-Up & Activation:

  • Oversee site-level activities for efficient site activation
  • Identify and assess potential research sites
  • Conduct site outreach, feasibility surveys, and engagement
  • Perform remote Pre-Study Visits (PSV) and documentation
  • Track site progress and ensure timelines are met

Regulatory & Compliance:

  • Ensure compliance with:
    • ICH-GCP guidelines
    • Local regulations and SOPs
  • Manage submissions to:
    • IRB/IEC
    • Regulatory Authorities
    • Third parties (if applicable)
  • Maintain and track regulatory documents
  • Support annual renewals, PI changes, and document updates

Documentation & TMF Management:

  • Collect, review, and track essential documents for site activation
  • Maintain Trial Master File (TMF) in audit-ready condition
  • Ensure accurate and timely document filing

Site Support & Coordination:

  • Act as the primary contact for investigative sites
  • Support CRA team in Site Initiation Visits (SIVs)
  • Coordinate with vendors and study teams for supplies and access
  • Assist in customization of Informed Consent Forms (ICFs) and patient materials

Contracts & Budgets:

  • Support initial contract and budget negotiations with sites
  • Assist with amendments where required

Monitoring & Data Review:

  • Perform remote monitoring activities as per plan
  • Conduct CRF review and data validation
  • Monitor for:
    • Protocol deviations
    • SAE reporting compliance

Risk Management & Issue Resolution:

  • Identify site-level risks and underperformance
  • Implement action plans and escalate issues when required
  • Participate in study team meetings

Training & Mentorship:

  • Act as a knowledge resource for junior team members
  • Support training and development activities

Qualifications (Minimum Required):

  • Bachelor’s degree (preferably in Life Sciences)
    OR certification in allied health (e.g., Nursing, Lab Technology)

OR

  • High School Diploma with 5+ years of clinical research experience
  • Strong knowledge of:
    • ICH-GCP guidelines
    • Regulatory Authorities (RA)
    • IRB/IEC processes
  • Fluency in local language and English (written & verbal)

Experience Required:

  • Minimum 2+ years in clinical development or start-up/regulatory roles
  • Experience with:
    • Site start-up documentation
    • Contract and budget negotiations
    • Interaction with project teams and investigative sites

Skills & Competencies:

  • Strong communication and stakeholder management skills
  • Ability to manage multiple tasks and deadlines
  • Good problem-solving and issue resolution abilities
  • Understanding of clinical trial protocols and regulations
  • Negotiation skills for contracts and budgets
  • Attention to detail and organizational skills

Work Environment:

  • Primarily remote-based role (with possible office presence)
  • Limited travel (mainly for training purposes)