Job Summary:
Seeking a talented, experienced and highly motivated Contract Clinical Trial Assistant of Clinical Operations with a passion for new cancer therapy development. This role will be responsible for assisting and supporting the Clinical Operations and cross functional team in the operational execution of one or more clinical trials from start-up through close out for our early stage clinical programs. As a CTA, you will be responsible for maintaining the Trial Master File (TMF) in an inspection-ready state, assisting with site management, initiating collection, reviewing and tracking of essential documents throughout the life of the trial. You will also contribute to the development, tracking and distribution of study materials and site/study communications. As a member of our dynamic group, you will help to grow the company's pipeline.
What you’ll do:
- Assist Clinical Operations team in the development, handling, distribution, filing and archiving of essential documents in the TMF
- Assist and/or contributes to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory documents, lab and pharmacy manuals, study binders, study plans, study communications and presentations
- Handle incoming and outgoing clinical trial related materials shipments to site, study team, CRAs and external vendors, as needed
- Assists with all aspects of collection, review, and tracking of site documents including 1572s, CVs, and financial disclosure documents of regulatory packets for initial study drug release to sites
- Assist clinical study team with the planning, preparation, and on-site support of investigators meetings
- Communicate directly with sites, Contract Research Organizations (CROs), vendors and CRAs to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close out activities
- Assist with tracking of study team training and clinical trial progress including status update reports, as requested
- Assist with routing of final sign-off of project and study-related documents as required
- Coordinate and schedule team meetings including preparation of agendas, minutes and tracking action items
- May be assigned other projects and duties as required
Requirements:
- BS/BA required
- Minimum 1-2 years of relevant experience in biotech or pharmaceutical industry; Study Coordinator experience preferred
- Results-driven, self-motivated, with initiative and able to take ownership of, and follow through with, specific tasks
- Exercise good judgment and make decision that is appropriate for the organization
- Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
- Strive for continuous improvement and embrace innovative ideas in daily work
- Demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Adobe Acrobat) and experience with SmartSheet is a plus
#INDZH
Pay: $50.00 - $60.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Education:
Experience:
- Veeva Vault: 1 year (Required)
- Sponsor CTA: 3 years (Required)
Work Location: Remote
