Type: 12 months contract
Location: Fully remote, East Coast, US
The Clinical Trial Assistant will assist in early to late clinical development operations (Phase I/II/III clinical trials) in the field of ophthalmology. This role will focus on providing clinical study support during start-up, maintenance and close out. Additionally, s/he will help to ensure clinical operational deliverables and timelines are met across the development program(s). Reporting to the Clinical Trial Manager or above, this individual will be responsible for overall operational support in management of multiple clinical trials, including:
* Support interdisciplinary activities, including preparation of materials and summaries for the Clinical Operations meetings in order to meet goals and establish timelines
* Generate, review and approve Trial Master File (TMF) document workflows and perform TMF review
* Assist in preparation of informed consent forms, review of regulatory packets, clinical study reports and other clinical documents as necessary
* Assist in the creation of study materials, including but not limited to documents, presentations, reports and study plans
* Conduct initial review and tracking of invoices and study payments
* Establish and maintain tracking tools for assigned trials including but not limited to lab sample management, invoice payments
* Participate in team meetings and assist in the preparation of agendas, minutes and tracking of action items
* Perform administrative tasks to support Clinical Operations and team members as needed
* Provide support to all aspects of study progress (from planning to close-out), to assure adherence to intended timelines and achievement of study goals, while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines.
* Bachelor’s degree (scientific or healthcare discipline preferred) plus at least 2-4 years in clinical and drug development
* Experience in ophthalmology a plus (but not required.)
* Knowledge of ICH GCP and knowledge of Medical Terminology strongly preferred
* Ability to organize and manage multiple priorities required
* Strong oral and written communication skills required
* Proficiency in Microsoft Word, Excel and PowerPoint required
* Ability to multitask with significant attention to detail
* Ability to work independently and in a matrix team environment
* Applies creative, original ideas to accomplish work; identifies more than one way to solve problems.
* Ability to act with a sense of urgency and with the result in mind; can follow through to deliver exceptional results.
* Taking an approach to continuous improvement; anticipates and addresses capability gaps to prepare for future challenges.
* Takes accountability as individuals and as teams, acts like an owner.
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