Site Navigator II

This is a fully remote position, open to applicants in Mexico, +1 more country.

📋 Description

• Oversee site-level tasks during the initiation and possibly the conclusion of clinical studies.

• Act as the primary contact for investigative sites from the feasibility stage and initial outreach to site activation and ongoing support.

• Ensure adherence to regulatory requirements, manage site operations, provide training, and foster collaboration among the sponsor, CRO, and clinical site personnel.

• Identify and evaluate potential research sites.

• Conduct initial outreach to sites, gather Confidentiality Agreements, and complete feasibility assessments.

• Perform remote Pre-Study Visits and complete necessary follow-up documentation.

• Assist in the customization and translation of informed consent forms and materials for patients.

• Gather, track, and conduct quality reviews of essential documents for site activation and ongoing regulatory compliance.

• Support annual renewals with IRB/IEC, manage Principal Investigator transitions, and oversee document expiration.

• Participate in team meetings, execute action plans for site-related risks and issues, and escalate concerns promptly.

• Aid CRA teams in preparing for site initiation visits and coordinate clinical study supplies, access, and documentation.

• Submit to and communicate with IRB/IEC, Third Bodies, and Regulatory Authorities.

• Engage in initial and adjusted contract and budget negotiations with research sites.

• Maintain robust filing systems and ensure the Trial Master File is audit-ready.

• Monitor start-up progress and ensure sites fulfill requirements and deadlines.

• Ensure accurate and timely system compliance to maintain Fortrea's audit readiness.

• Serve as the main point of contact for investigative sites and ensure deliverables are met within scope and budget.

• Review Case Report Forms and validate source data, monitor protocol deviations, and report Serious Adverse Events.

• Review and customize informed consent forms for specific countries and sites.

• Undertake additional assigned responsibilities.

⛳️ Requirements

• A University/College degree (preferably in life sciences) or certification in a relevant allied health profession from a recognized accredited institution (such as nursing certification, medical, or laboratory technology), or a minimum of 3 years of experience in clinical research.

• Fortrea may accept relevant and equivalent experience instead of formal educational qualifications.

• A High School Diploma or equivalent AND at least 5 years of experience in clinical research may be accepted as an alternative to the above requirement.

• Strong understanding of ICH/GCP guidelines and RA, IRB/IEC regulations.

• Fluency in the local official language and in English, both written and spoken.

• At least 2 years of experience in clinical development or the start-up/regulatory process.

• Familiarity with investigator start-up documentation and the contract/budget negotiation process.

• Previous experience interacting with operational project teams and investigative sites.

• Comprehensive understanding of research protocol requirements and the ability to communicate and educate others about them.

• Strong communication skills with site staff, CRO personnel, and regulatory authorities.

• Capability to manage multiple tasks and deadlines concurrently.

• Knowledge of clinical trial and research regulations and guidelines.

• Proficiency in identifying and resolving potential issues during the start-up phase.

• Competence in effectively negotiating contracts and budgets with research sites.

🏝️ Benefits

• Opportunity for remote work.

• Limited travel required solely for training purposes.