CRO-Clinical Trials Assistant (remote)

Essential Duties and Responsibilities

• Aid in the preparation of documents such as regulatory document templates, study binders, study communications, and presentations.
• Manage clinical, regulatory, and study-related essential documents like study protocols, Informed Consent Forms, etc.
• Assist with initial study drug release, including regulatory packet review and study-drug release.
• Prepare and develop study-specific training materials.
• Participate in the planning of investigator meetings.
• Interact with sites as needed to address issues.
• Handle incoming and outgoing shipments as needed.
• Maintain and track monitoring visit reports.
• Track and compile enrollment updates and reports weekly.
• Support the review of clinical data at various levels.
• File and quality check trial master files in a timely and accurate manner.
• Update and maintain training records for the study team.
• Document changes in study team members and complete Study Plan Checklists as assigned.
• Identify and escalate issues appropriately.
• Act as a central point of contact for the clinical team for designated project communications, correspondence, and documentation.
• Perform data entry into designated clinical tracking systems according to project requirements.

Qualifications

• BS/BA preferred, high school diploma/certificate or equivalent required.
• Minimum of 2 years of clinical research experience required; 1 year CTA experience preferred.
• Demonstrated organizational and coordination skills with attention to detail.
• Solid understanding of clinical drug development is preferred.