Senior Site Navigator

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

📋 Description

• Oversee site-level operations during the initiation and potential closure of clinical studies.

• Act as the primary liaison for investigative sites from the feasibility stage through activation and ongoing support.

• Ensure adherence to regulatory standards, effective site management, comprehensive site support and training, and collaboration among sponsors, CROs, and clinical site personnel.

• Serve as the local expert on study initiation activities.

• Provide mentorship and training to junior team members as necessary.

• Recognize and address issues that might cause delays in studies.

• Evaluate and identify suitable research sites.

• Conduct outreach to sites, gather confidentiality agreements, and perform feasibility assessments.

• Execute remote pre-study visits and complete necessary follow-up documentation.

• Assist in customizing and translating informed consent forms and materials intended for patients.

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

• Facilitate IRB/IEC renewals, changes in Principal Investigators, and monitor document expiration dates.

• Engage in study team meetings and formulate action plans for addressing site-specific risks and challenges.

• Aid CRA teams in preparing for site initiation visits, coordinating vendors, supplies, access, and distributing documents.

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

• Conduct initial and revised contract and budget negotiations with research sites.

• Uphold high-quality filing systems and maintain an audit-ready Trial Master File.

• Monitor start-up progress alongside site requirements and deadlines.

• Ensure ongoing compliance to maintain Fortrea's audit readiness.

• Act as the main contact for investigative sites, ensuring timely service delivery within the defined scope and budget.

• Review CRFs and validate source data, monitor protocol deviations, and manage SAE reporting.

• Evaluate and customize country and site-specific informed consent forms.

• Undertake other assigned responsibilities.

⛳️ Requirements

• Bachelor’s degree (preferably in life sciences) or certification in a related allied health field from an accredited institution (e.g., nursing certification, medical or laboratory technology), or 3–5 years of relevant experience in clinical research.

• Equivalent relevant experience may substitute for formal educational qualifications.

• A High School Diploma or equivalent with a minimum of 5 years of experience in clinical research may also be considered.

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

• Proficient in both the local official language and English, in written and verbal forms.

• At least 3 years of experience in clinical development or the start-up/regulatory process.

• Comprehensive knowledge of ICH/GCP, RA, IRB/IEC, and other relevant regulations and guidelines.

• Familiar with investigator start-up documents and the contract/budget negotiation process.

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

• Understanding of research protocol requirements and the ability to effectively communicate and educate others about them.

• Capacity to manage multiple tasks and deadlines concurrently.

• Skill in identifying and resolving potential start-up challenges.

• Proficient in negotiating contracts and budgets with research sites.

🏝️ Benefits

• Requirement for remote work with potential office presence depending on location.

• Limited travel required solely for training purposes.

• Equal Employment Opportunity (EEO) and accommodation support provided.