Site Navigator I - Remote US & Canada

Fortrea•Durham, CA

3d•$58,000 - $63,000•Remote

About The Position

Site Navigators coordinate site-level activities during clinical study start-up and, as needed, through study maintenance and closeout. They serve as the primary contact for investigative sites, supporting progression from feasibility and initial outreach through site activation while ensuring regulatory compliance, site management, site support and training, and collaboration among sponsors, CROs, and clinical site staff. The role involves applying independent judgment to manage site activities, address issues, and support study timelines and compliance. It also includes responsibilities such as site document and regulatory management, contract and budget negotiations, and—in some cases—CRF review and data validation during the study. This is a remote-based role for the US and Canada, with possible office presence depending on location. Travel is described as limited to training; the work environment section also mentions frequent travel to client or site locations and occasional domestic and international travel. Work is performed in an office environment with exposure to electrical office equipment. Varied hours may be required.

Requirements

University or college degree, preferably in life science; alternatively, certification in a related allied health profession from an accredited institution, or 2–3 years of clinical research work experience including working knowledge of ICH/GCP guidelines and RA and IRB/IEC regulations.
Relevant equivalent experience may be considered in lieu of educational requirements.
Alternatively, a high school diploma or equivalent and at least 5 years of clinical research work experience, including strong working knowledge of ICH/GCP guidelines and RA and IRB/IEC regulations.
Fluency in the local official language and English, both written and verbal.
At least one year of experience in a related field, such as medical, clinical, pharmaceutical, laboratory research, data analysis, data management, or technical writing.
Basic knowledge of ICH/GCP, RA, IRB/IEC, and other applicable regulations and guidelines.
Demonstrated understanding of research protocol requirements.
Effective communication with site staff, CRO personnel, regulatory authorities, and other stakeholders.
Ability to manage multiple tasks and deadlines simultaneously and meet requirements on time.
Ability to identify and resolve potential issues during the start-up process.
Ability to negotiate contracts and budgets effectively with research sites.
Ability to sit for extended periods and operate a vehicle safely.
Repetitive hand movement and ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Ability to access and use a variety of in-house and off-the-shelf computer software.
Ability to lift and carry light to moderate loads, including luggage and a laptop, up to 15–20 lbs.
Regular and consistent attendance.

Nice To Haves

A scientific degree and/or clinical expertise is optimal.
One year of clinical research experience is preferred.
Familiarity with investigator start-up documents and the contract and budget negotiation process is preferred.
Previous interaction with operational project teams and investigative sites is preferred.

Responsibilities

Oversee site-level tasks for efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs, and project requirements, collaborating with project leadership and local monitors while protecting study participant rights, wellbeing, and safety.
Identify potential research sites that meet study criteria and assess their capabilities and resources.
Conduct initial site outreach, including site engagement and collection of confidentiality agreements and feasibility surveys.
Manage site-level activities independently, resolve issues, and make decisions supporting study timelines and compliance.
Conduct remote pre-study visits and complete follow-up documentation, including visit preparation and trip reports, to support site selection.
Support customization and translation of informed consent forms and patient-facing materials.
Collect, track, and quality-review essential documents for site activation; monitor ongoing site regulatory compliance and support applicable IRB/IEC renewals, PI changes, and document expirations.
Participate in study team meetings, develop and implement action plans for site-level risks or issues, and escalate issues in a timely manner.
Support CRA preparation for site initiation visits by coordinating with vendors, supplies teams, and study leads on distribution of study supplies, access, and documents.
Submit to and liaise with applicable IRBs/IECs, Third Bodies where applicable, and Regulatory Authorities in collaboration with the Global Regulatory Submissions Lead.
Conduct initial contract and budget negotiations with sites and amendments where applicable.
File quality documents in applicable systems according to SOPs and project requirements, and keep the TMF updated and audit ready.
Track start-up progress and ensure sites meet requirements and deadlines.
Maintain accurate, timely, and consistent system compliance to support audit readiness.
Serve as the primary contact for investigative sites and ensure timely delivery in alignment with scope of work and study budget.
Perform CRF review and data validation against source documentation, as applicable, and monitor site protocol deviations and SAE reporting, along with other assigned study duties.
Review and customize country- and site-level informed consent forms in accordance with local requirements.
Perform other duties as needed or assigned.