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 currents lists of correspondence.

Essential Duties and Responsibilities:

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 with tracking of clinical trial progress, as assigned.

Assist PM with set up and preparation of project meetings. May include scheduling the calls, gathering updates from the team, drafting, and finalizing of agenda, sending agenda to the team, and drafting and finalizing minutes.

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.

Performs data entry into designated clinical tracking systems in accordance with project requirements, including collection of information from designated clinical team members, CROs, vendors, etc.

Performs other miscellaneous related duties, as required.

Education and/or Experience:

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.

Skills and Abilities:

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.