Site Navigator II – Clinical Start-Up Specialist
Location: Bangalore, India
Job Type: Full-Time
Category: Clinical Operations / Clinical Research
Experience Required: Minimum 2+ years
Job Overview
The Site Navigator II plays a pivotal role in the successful execution of clinical trial start-up activities, ensuring seamless coordination between sponsors, CROs, and investigative sites. This role is responsible for managing site activation processes, maintaining regulatory compliance, and supporting clinical sites from feasibility through activation and maintenance phases. Acting as a subject matter expert, the Site Navigator II contributes to operational excellence while mentoring junior team members and ensuring adherence to global clinical research standards.
Key Responsibilities
Manage and oversee site-level activities related to clinical study start-up, ensuring alignment with ICH-GCP guidelines, regulatory requirements, and project timelines. Identify and evaluate potential research sites based on study feasibility, capabilities, and resource availability. Conduct site outreach, including engagement, confidentiality agreements, and feasibility assessments to support site selection. Coordinate remote pre-study visits, prepare documentation, and ensure compliance with sponsor and regulatory expectations. Support the preparation, customization, and translation of informed consent forms and patient-facing materials. Collect, review, and track essential regulatory documents required for site activation while ensuring continuous compliance throughout the study lifecycle. Collaborate with cross-functional teams to address risks, resolve issues, and maintain project milestones. Assist Clinical Research Associates (CRAs) in site initiation activities, including coordination of study supplies, systems access, and documentation readiness. Liaise with Institutional Review Boards (IRB), Independent Ethics Committees (IEC), and regulatory authorities for submissions and approvals. Support site contract and budget negotiations, ensuring alignment with study requirements. Maintain accurate and audit-ready Trial Master File (TMF) documentation in compliance with SOPs. Monitor study start-up progress, ensuring adherence to timelines and regulatory standards. Perform remote monitoring activities, including source data verification and case report form review where applicable.
Education and Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related healthcare discipline is preferred. Candidates with relevant certifications in allied health professions or equivalent clinical research experience will also be considered. Strong understanding of ICH-GCP guidelines, regulatory requirements, and clinical trial processes is essential.
Experience Requirements
A minimum of 2+ years of experience in clinical research, study start-up, or regulatory processes is required. Prior experience working with investigative sites, CROs, and regulatory bodies is highly desirable. Familiarity with clinical trial documentation, site activation processes, and contract/budget negotiations is essential.
Key Skills and Competencies
Strong knowledge of global clinical trial regulations, including ICH-GCP, IRB/IEC, and regulatory authority requirements. Excellent communication and stakeholder management skills to effectively collaborate with internal teams, sponsors, and site personnel. Ability to manage multiple projects simultaneously while meeting strict deadlines. Strong problem-solving and risk management capabilities in clinical operations. Proficiency in clinical trial systems, documentation management, and regulatory submissions. High attention to detail with a focus on compliance, accuracy, and audit readiness.
Work Environment
This is a primarily remote-based role with occasional office presence depending on business requirements. Limited travel may be required for training and project needs.
Why Join This Role
This opportunity offers exposure to global clinical research projects, enabling professionals to build expertise in clinical trial start-up and regulatory processes while contributing to the advancement of innovative healthcare solutions.
Uttar Pradesh :
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Canada |Quebec :
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Brazil | Sao paulo |Attica :
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Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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