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.
Summary of Responsibilities:
The role provides support and assistance across the following activities:
- Oversight of site-level tasks associated with efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs, and project requirements
- 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
- 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
- Actively participate in study team meetings to support study progress
- Support the CRA team in preparing for site initiation visits
- Responsible for submissions to and liaise 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
- Track the progress of the start-up process and ensure that the research site meets all requirements and deadlines
- Ensure Fortrea is audit-ready
- Serve as primary contact for investigative sites
- Perform remote visits as required by the monitoring plan
- Perform Case Report Form review and data validation against source documentation
Qualifications (Minimum Required):
- Currently enrolled in or recently graduated from a University degree program in life sciences
- Demonstrated interest in clinical research
- Strong organisational 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
Preferred Skills
- Familiarity with Good Clinical Practice and clinical trial processes