other
Posted 2 weeks agoSite Navigator I
at Fortrea
Manila, PhilippinesRemote
Responsibilities
- 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.
- 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 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
- Perform country and site ICF review/customization, per local
Requirements
- 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
- 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
- Qualifications (Minimum Required): Pharmacist highly desired but open to other life science degree At least one year of
- experience in a related field, (e.g., medical, clinical, pharmaceutical, laboratory research, data analysis, data management or technical writing).
- One year of clinical research is preferred Strong working knowledge of the ICH/GCP guidelines and RA, IRB/IEC regulations Fluent in local official language and in English, both written and verbal.
- Basic knowledge of ICH/GCP, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites is preferred.