[Hiring] Clinical Trials Assistant @Evolution Research Group

Role Description

The Clinical Trials Assistant supports Clinical Operations to ensure studies are completed, on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. The CTA will archive and organize clinical trial master file documents, including clinical study site documents, generate filing indexes and maintain current lists of correspondence.

• Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations.
• Manage clinical, regulatory, and study-related essential documents such as study protocols, Informed Consent Forms, etc.
• Assist with all aspects of initial study drug release including regulatory packet review and study-drug release.
• Assist in the preparation and development of study-specific training materials.
• Participate in the planning of investigator meetings.
• Interact with sites as needed to respond to issues.
• Handle incoming and outgoing shipments, as needed.
• Monitor and track monitoring visit reports.
• Assist with tracking of clinical trial progress including status update reports, as required.
• Participate in the review of clinical data at the case report form, data listing, and report table levels.
• Collect enrollment updates and reports on a weekly basis.
• Assist PM with set up and preparation of project meetings.
• File and QC trial master files.
• Ensure documents are filed/uploaded into the eTMF in a timely and accurate manner.
• Review and maintain up-to-date training records for the study team.
• Document changes in study team members including updating the Study Contact Sheet.
• Complete Study Plan Checklist for study Plans as assigned.
• Identify and escalate issues appropriately.
• May act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
• Perform data entry into designated clinical tracking systems in accordance with project requirements.
• Perform other miscellaneous related duties, as required.

Qualifications

• BS/BA preferred. High school diploma/certificate or educational equivalent required.
• Must possess a general knowledge of applicable clinical research requirements, including GCP and ICH guidelines.
• Minimum of 2 years of clinical research experience required; one year CTA experience preferred but not required.
• Demonstrated organizational and coordination skills with attention to detail.
• Solid understanding of clinical drug development is preferred.

Requirements

• Strong Microsoft Office skills.
• Strong written and verbal communication skills.
• Effective time management and organizational skills.
• Attention to detail and accuracy in work.
• Strong customer service orientation.
• Ability to work effectively and efficiently handling multiple tasks simultaneously.
• Ability to facilitate a teamwork philosophy with a positive attitude.