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:

Bachelor's (Required)

Experience:

Veeva Vault: 1 year (Required)
Sponsor CTA: 3 years (Required)

Work Location: Remote

TotalMed jobs

Remote - Clinical Trial Assistant (CTA)