[Hiring] Clinical Research Intern @Fortrea

Role Description

The Site Navigator Intern supports site-level activities throughout study start-up, 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.

• Oversight of site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs, and project requirements.
• Collaboration with project leadership and local monitors to achieve project milestones while 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, including site engagement, collection of Confidentiality Agreement, and 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.
• 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.
• Maintenance and ongoing awareness of site regulatory compliance, supporting annual IRB/IEC renewals, PI changes, and document expirations.
• Actively participate in study team meetings to support study progress and develop action plans for site-level risks.
• Support the CRA team in preparing for site initiation visits (SIVs) by coordinating with vendors, supplies teams, and study leads.
• Responsible for submissions to and liaising with applicable IRB/IEC, Third Bodies, and Regulatory Authorities.
• Perform initial contract and budget negotiations with the sites.
• Ensure high-quality documents are filed in applicable systems in accordance with SOPs and project requirements.
• 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.
• 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.
• Perform Case Report Form (CRF) review and data validation against source documentation according to protocol and guidelines.
• Perform country and site ICF review/customization, per local requirements.
• All other duties as needed or assigned.

Qualifications

• 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.

Requirements

• 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.