SUMMARY DESCRIPTION The Clinical Trial Assistant (CTA) is responsible for the document management processes involved in the planning, initiation, conduct, tracking, and completion of clinical trials in accordance with regulations and SOPs. The CTA uses solid judgment and independent decision-making to assess and manage technical study documents and key clinical monitoring activities and is a key resource for Clinical Operations study leads. The CTA manages the Trial Master File (TMF) for assigned studies and establishes and maintains the electronic clinical trial management system (CTMS) for assigned studies.
*Seeking someone who can travel to NYC periodically but work remote most of the time.
Assist with all phases of clinical study activities (feasibility, start-up, maintenance, and close-out).
Collect and review essential regulatory documents prior to site initiation/study drug release.
Create and maintain study trackers (e.g., contact lists, study status trackers, enrollment).
Maintain up to date information in CTMS.
Participate in creation and user acceptance testing for EDC and other systems, as required.
Assist the project team in preparation and distribution of study documents (e.g, consent form, study reference manual, regulatory binder, and newsletters).
Support field-based clinical study monitors.
Participate in study team and vendor meetings. Schedule meetings and draft meeting minutes/distribute final minutes, as needed.
Maintenance of the electronic TMF.
Assist with quality and validity of clinical trial data.
Provide clerical support and administrative activities for project team (e.g., shipment of study materials, proofreading and editing correspondence).
All other duties as required.
Bachelor’s or Master’s degree in a scientific discipline.
Knowledge of ICH GCP and FDA regulatory requirements is required.
Research or health care related academic or work experience preferable.
Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.
Good written and verbal communication skills.
Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook.
This position will compensate between $40,000-$50,000 depending on experience.
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