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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
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Qualifications
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- 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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