The Site Navigator Intern supports site-level activities throughout study start-up and, maintenance and closeout. Under the guidance of experienced team members, the intern assists with feasibility, site outreach, site activation, regulatory compliance, and site support, while gaining practical experience in clinical research operations and cross-functional collaboration.
Summary of Responsibilities:
The role provides support and assistance across the following activities, as applicable and in accordance with the assigned scope of responsibilities:
- Oversight of site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs and project requirements, including collaboration with project leadership and local monitors to collaboratively achieve project milestones while also ensuring Study Participant rights, wellbeing and safety are protected
- Identifying potential research sites that align with the study's criteria and assessing their capabilities and resources
- Conduct initial site outreach, i.e., site engagement, collection of Confidentiality Agreement, and collection of feasibility survey
- Apply independent judgment and discretion in managing site-level activities, resolving issues, and making decisions that support study timelines and compliance requirements.
- Remote Pre-Study Visits and follow up documentation, including visit preparation, trip report completion, and other documentation as required to support site selection in line with sponsor, protocol, local and country regulations and requirements
- Support customization and translation of informed consent forms and patient-facing materials.
- Collect, track and perform a quality review of all essential documents required for effective and compliant study site activation from site outreach, submissions, greenlight and until site activation. Maintenance and ongoing awareness of site regulatory compliance, supporting annual IRB/Independent Ethics Committee (IEC) renewals, PI changes, and document expirations will be performed as applicable in compliance with local requirements.
- Actively participate in study team meetings to support study progress, develop and implement action plans for site level risks, underperforming sites, or issues impacting project milestones and escalate issues in a timely manner
- Support the CRA team in preparing for site initiation visits (SIVs) by coordinating with vendors, supplies teams, and study leads to ensure timely distribution of clinical study supplies, accesses and documents per study team guidance
- Responsible for submissions to and liaise with applicable IRB/IEC, Third Bodies (if applicable), and Regulatory Authorities by collaborating with Global Regulatory Submissions Lead (GRSL)
- Perform initial contract and budget negotiations with the sites, as well as amended where applicable.
- Ensure high quality documents are filed in applicable systems in accordance with SOPs and project requirements and that the Trial Master File (TMF) is updated and audit ready at all times.
- Track the progress of the start-up process and ensure that the research site meets all requirements and deadlines.
- Ensure Fortrea is audit ready by completing accurate, timely, and consistent system compliance on an ongoing basis
- Serve as primary contact for investigative sites and ensure timely delivery in alignment with scope of work/study budget
- Perform remote visits as required by the monitoring plan including remote monitoring that may require SDV/SDR after successful completion of the MEA SDR/SDV training.
- Perform Case Report Form (CRF) review and data validation against source documentation according to protocol and guidelines as applicable in combination with monitoring for site protocol deviations, Serious Adverse Event (SAE) reporting, and all other duties as needed or assigned throughout the course of the study.
- Perform country and site ICF review/customization, per local requirements
- All other duties as needed or assigned
Qualifications (Minimum Required):
- Currently enrolled in or recently graduated from a University degree program in life sciences.
- Demonstrated interest in clinical research
- Strong organizational and time-management skills.
- Detail-oriented with a commitment to high-quality work.
- Effective communication skills and ability to work collaboratively.
- Fluent in local official language and in English, both written and verbal
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to handle confidential information with discretion.
Preferred Skills
- Familiarity with Good Clinical Practice (GCP) and clinical trial processes.
Physical Requirements:
- Frequently stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Regular and consistent attendance.
- Varied hours may be required.
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