Manage clinical trial site start‑up activities and act as primary site contact. Conduct site identification, feasibility, regulatory and ethics submissions, contract/budget support, remote pre‑study visits and SIV preparation. Perform in‑house/remote CRA tasks (document and CRF review, data validation) after training, maintain inspection‑ready TMF, and collaborate with CRAs and project teams to meet study milestones.
Site Navigator I
Location: remote
We are looking for a clinical operations professional to join our team as Site Navigator I, managing clinical trial start‑up activities with additional in‑house CRA responsibilities. This is an excellent, comprehensive role for someone looking to grow their career in clinical research within a global CRO environment.
Key Responsibilities
- Perform site identification, feasibility, and start‑up activities, including site outreach, feasibility questionnaires, and confidentiality agreements
- Coordinate and track essential regulatory documents to ensure timely and compliant site activation
- Act as a primary point of contact for investigative sites during the start‑up and possibly the maintenance phase
- Perform ethics committee and regulatory authority submissions, renewals, and prepare the relevant regulatory documentation in collaboration with internal teams
- Perform site contract and budget negotiations under guidance
- Perform remote Pre-Study Visits
- Support Site Initiation Visit (SIV) preparation, including coordination of documents, systems access, and study supplies
- Perform remote/in‑house CRA activities, such as document review, CRF review, data validation, and remote monitoring tasks (after required training)
- Maintain accurate documentation in study systems and ensure the TMF is inspection‑ready
- Collaborate closely with CRAs, project teams, and study stakeholders to support study milestones
Qualifications
- University degree (life sciences preferred)
- Minimum 1 year experience in Clinical Operations or Start-Up
- Knowledge of ICH/GCP and clinical trial processes
- Strong organizational skills, attention to detail, effective communication and willingness to learn
- Ability to manage multiple tasks in a structured and proactive way
Learn more about our EEO & Accommodations request here.
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