Site Navigator I

Jobgether; India; Teletrabalho; INR 600 000 - 900 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Remote work

Professional development

Cross-functional exposure

Career growth

Impactful work

Resumo da oferta

Jobgether is partnering with a research organization to recruit a Site Navigator I based in India. The role focuses on coordinating clinical site activities, feasibility, regulatory submissions, and activation milestones to ensure efficient study start-up.

You will serve as the primary contact for investigative sites, support budgets and contracts, and ensure compliance with ICH/GCP and local regulations while collaborating with sponsors, CROs, and study teams in a remote-friendly setup.

Qualificações

• University or college degree in life sciences or allied health.
• Alternative pathway: high school diploma with 5 years clinical research experience.
• Minimum 1 year experience in clinical research or related field.
• Basic understanding of ICH/GCP and regulatory requirements.

Responsabilidades

• Identify investigative sites and assess capabilities.
• Coordinate site start-up through activation and track milestones.
• Collect and maintain essential site documents per ICH/GCP guidelines.
• Coordinate remote pre-study visits and prepare reports.
• Prepare regulatory submissions to IRBs/IECs and authorities.
• Assist with informed consent customization and translations.
• Monitor renewals, PI changes and ongoing compliance.
• Support contract and budget negotiations with sites.
• Collaborate with CRAs, sponsors, CROs, and site staff.
• Support site initiation visits with supplies and access.
• Identify risks and escalate to protect timelines.
• Maintain Trial Master File and data quality checks.
• Exercise independent judgment in site activities.

Conhecimentos

Detail oriented

Communication skills

Organization

Remote work readiness

Regulatory awareness

Problem solving

Negotiation & coordination

Formação académica

Life sciences degree

Alternative pathway (high school + 5 years CR exp.)

Descrição da oferta de emprego

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Site Navigator I based in India.

We are seeking a detail-oriented Site Navigator I to coordinate clinical trial site activities and support the successful start-up and activation of research sites. In this role, you will serve as a primary point of contact for investigative sites, facilitating communication between clinical teams, sponsors, CROs, and regulatory stakeholders. You will oversee site feasibility, initial outreach, essential documentation, regulatory submissions, and activation milestones to ensure studies progress efficiently. Working within established clinical research standards, you will help maintain compliance with ICH/GCP guidelines, local regulations, and study-specific requirements. You will also support site contracts, budgets, training, and ongoing documentation management while proactively identifying risks that could affect study timelines. This remote opportunity is ideal for an organized professional who values patient safety, operational excellence, and collaboration in a regulated clinical research environment.

Accountabilities

• Site Identification and Feasibility: Identify potential investigative sites that meet study requirements, assess their capabilities and resources, conduct initial outreach, obtain confidentiality agreements, and coordinate feasibility questionnaires.
• Site Start-Up and Activation: Coordinate site-level start-up activities from feasibility through activation, tracking milestones, deadlines, submissions, and outstanding requirements to ensure timely study initiation.
• Regulatory Compliance and Documentation: Collect, review, track, and maintain essential site documents in accordance with ICH/GCP guidelines, applicable regulations, standard operating procedures, and study-specific requirements.
• Pre-Study Visits: Coordinate remote pre-study visits, including preparation, follow-up activities, visit reports, and supporting documentation required for site selection and activation.
• Regulatory Submissions: Prepare and coordinate submissions to Institutional Review Boards (IRBs), Independent Ethics Committees (IECs), applicable third parties, and regulatory authorities in collaboration with the relevant regulatory submissions team.
• Informed Consent Management: Review and support the customization and translation of informed consent forms and patient-facing materials to meet country-specific and local regulatory requirements.
• Site Maintenance and Regulatory Oversight: Monitor document expirations, annual ethics committee renewals, principal investigator changes, and other ongoing compliance requirements throughout the study, as applicable.
• Contract and Budget Coordination: Conduct initial contract and budget negotiations with investigative sites and support amendments when required, ensuring alignment with study scope and budget expectations.
• Cross-Functional Collaboration: Work closely with project leadership, Clinical Research Associates (CRAs), study leads, sponsors, CRO personnel, vendors, and site staff to coordinate deliverables and resolve operational issues.
• Site Initiation Support: Assist CRA teams in preparing for site initiation visits by coordinating clinical supplies, system access, documentation, and other site readiness requirements.
• Risk Management and Escalation: Participate in study team meetings, identify site-level risks and performance issues, develop action plans, and escalation concerns promptly to protect project timelines and study quality.
• Trial Master File Management: Ensure accurate, timely, and consistent filing of essential documents in applicable systems and maintain an audit-ready Trial Master File (TMF).
• Clinical Data Quality and Monitoring Support: Perform Case Report Form (CRF) reviews and data validation against source documentation, as applicable, while supporting the identification of protocol deviations, serious adverse event reporting requirements, and other study compliance matters.
• Operational Excellence: Exercise independent judgment in managing site activities, resolving issues, prioritizing competing deadlines, and completing additional responsibilities in line with operational requirements and internal training.

Requirements

• Education: A university or college degree, preferably in life sciences, or a relevant qualification in an allied health profession, such as nursing, medical technology, or laboratory technology. Equivalent relevant professional experience may be considered.
• Alternative Qualification Pathway: Candidates with a high school diploma or equivalent and at least five years of clinical research experience, including strong knowledge of applicable regulations, may also be considered.
• Professional Experience: At least one year of experience in a related field, such as clinical research, healthcare, pharmaceuticals, laboratory research, data analysis, data management, or technical writing. Previous clinical research experience is preferred.
• Clinical Research Knowledge: Basic understanding of ICH/GCP guidelines, regulatory authority requirements, IRB/IEC processes, and applicable clinical trial regulations.
• Site Start-Up Experience: Familiarity with investigator site start-up documentation, feasibility assessments, regulatory submissions, site activation processes, and contract and budget negotiations is advantageous.
• Protocol Understanding: Ability to interpret clinical study protocols and understand their implications for site readiness, documentation, compliance, and study execution.
• Documentation and Quality Control: Strong attention to detail and the ability to review, organize, track, and maintain accurate regulatory and essential study documents.
• Communication Skills: Excellent written and verbal communication skills in English and the applicable local official language, with the ability to communicate effectively with site personnel, sponsors, CRO teams, and regulatory stakeholders.
• Organization and Time Management: Ability to manage multiple projects, competing priorities, and strict deadlines while maintaining accuracy and consistency.
• Problem-Solving and Judgment: Strong analytical skills and the ability to identify potential site start-up challenges, resolve routine issues, and escalation complex concerns appropriately.
• Negotiation and Coordination: Ability to support contract and budget negotiations, coordinate cross-functional activities, and maintain productive relationships with investigative sites.
• Compliance Mindset: Commitment to patient rights, safety, confidentiality, regulatory compliance, and the ethical conduct of clinical research.
• Remote Work Readiness: Ability to work effectively in a remote environment and collaborate with geographically distributed clinical research teams.

Benefits

• Remote Work: Remote-based working arrangement, with possible office attendance depending on location.
• Limited Travel: Travel requirements are limited primarily to training.
• Professional Development: Opportunity to strengthen expertise in clinical trial start-up, regulatory documentation, site management, and clinical research operations.
• Cross-Functional Exposure: Work collaboratively with sponsors, CRO teams, investigators, regulatory stakeholders, and clinical operations professionals.
• Career Growth: Opportunity to develop clinical research knowledge and take on additional responsibilities aligned with operational needs and internal training.
• Meaningful Impact: Contribute to the successful delivery of clinical studies while supporting participant safety, regulatory compliance, and research quality.
• Compensation and Additional Benefits: Salary, healthcare coverage, paid leave, and other benefits were not specified in the original job description and should be confirmed during recruitment.