Site Navigator I, II

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

📋 Description

• Coordinate activities at the site level during the initiation and possible conclusion of clinical studies.

• Act as the main point of contact for investigative sites.

• Identify and evaluate potential research sites.

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

• Oversee remote pre-study visits and ensure follow-up documentation is completed.

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

• Gather, monitor, and perform quality checks on essential documents needed for site activation.

• Uphold regulatory compliance at sites and assist with IRB/IEC renewals, changes in Principal Investigators, and document expiration management.

• Engage in study team meetings and create action plans to address site-level risks and challenges.

• Aid CRA teams in preparing for site initiation visits and coordinating necessary supplies, access, and documentation.

• Submit applications to and communicate with IRB/IEC, third-party organizations, and regulatory authorities.

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

• Maintain audit-ready filing systems and keep the Trial Master File updated.

• Monitor start-up progress and ensure that sites meet established requirements and deadlines.

• Serve as the primary liaison for investigative sites, ensuring timely delivery within the defined scope and budget.

• Conduct reviews of CRFs and source data validation, while monitoring protocol deviations and serious adverse event reporting.

• Review and customize informed consent forms for both the country and site levels.

• Perform additional assigned tasks throughout the duration of the study.

⛳️ Requirements

• A university or college degree in a relevant field, preferably in life sciences, or certification in a related allied health profession.

• Alternatively, 2–3 years of experience in clinical research may be considered in lieu of educational qualifications.

• Alternatively, a High School Diploma or equivalent along with a minimum of 5 years of clinical research experience.

• At least 1 year of experience in a related field is required.

• One year of clinical research experience is preferred.

• Proficient knowledge of ICH/GCP guidelines and regulations pertaining to regulatory authorities and IRB/IEC.

• Familiarity with investigator start-up documents and the processes involved in contract and budget negotiations.

• Understanding of research protocol requirements.

• Fluent in both the local official language and English, with strong written and verbal communication skills.

• Ability to manage multiple tasks and meet deadlines effectively.

• Skill in identifying and resolving start-up issues.

• Competence in negotiating contracts and budgets with research sites.

• Proficiency in using both in-house and commercially available computer software.

• Ability to sit for extended periods and operate a vehicle safely.

• Consistent and regular attendance is required; flexibility in hours may be necessary.

🏝️ Benefits

• Opportunity to work remotely.

• Travel is limited to training purposes only.

• Equal Employment Opportunity (EEO) and accommodation support.

• Access to Global Talent Network opportunities.

• Career prospects contributing to life-saving therapies.

• A collaborative and excellence-driven work environment.