CRO – Clinical Trials Assistant

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide support to Clinical Operations to ensure that studies are completed punctually, within budget, and in adherence to SOPs, FDA regulations, and ICH/GCP guidelines.

• Archive and arrange clinical trial master file documents, which includes clinical study site documentation, generating filing indexes, and maintaining current correspondence lists.

• Assist in the preparation of various documents, such as regulatory document templates, study binders, study communications, and presentations.

• Manage essential clinical, regulatory, and study-related documents including study protocols, Informed Consent Forms, and more.

• Support all facets of the initial study drug release process, including the review of regulatory packets and the release of study drugs.

• Aid in the preparation and creation of study-specific training materials.

• Take part in the planning of investigator meetings.

• Engage with sites as necessary to address issues.

• Manage incoming and outgoing shipments as required.

• Monitor and track reports from monitoring visits.

• Gather enrollment updates and reports on a weekly basis.

• Assist the Project Manager with the setup and preparation of project meetings.

⛳️ Requirements

• Bachelor’s degree (BS/BA) is preferred.

• A high school diploma/certificate or equivalent educational background is required.

• A minimum of 2 years of experience in clinical research is required; one year of Clinical Trial Assistant experience is preferred but not mandatory.

• Must have a foundational knowledge of applicable clinical research requirements, including GCP and ICH guidelines.

• Strong organizational and coordination abilities with a keen attention to detail are essential.

• A solid understanding of clinical drug development is preferred.

🏝️ Benefits

• Comprehensive health insurance plans.

• Opportunities for professional development and training.

• Flexible working conditions to promote work-life balance.

• Competitive salary and performance-based incentives.