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 conducted on schedule, within budget, and in accordance with SOPs, FDA regulations, and ICH/GCP guidelines.

• Organize and archive documents related to the clinical trial master file, including those from clinical study sites, while generating filing indexes and maintaining current correspondence lists.

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

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

• Assist with all facets of the initial release of study drugs, including the review of regulatory packets and the release of study drugs.

• Support the creation and development of study-specific training materials.

• Engage in the planning of investigator meetings.

• Communicate with sites as necessary to address any issues that arise.

• Manage incoming and outgoing shipments as required.

• Track and monitor visit reports from monitoring activities.

• Gather and report enrollment updates on a weekly basis.

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

⛳️ Requirements

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

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

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

• A solid understanding of applicable clinical research requirements, including GCP and ICH guidelines, is essential.

• Proven organizational and coordination abilities with a keen attention to detail.

• A strong understanding of clinical drug development is preferred.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• Collaborative and dynamic work environment.

• Flexible working hours and remote work options.