Clinical Study Assistant

This position is remote in the eastern time zone and is a full-time role offering full benefit options. As a Kelly FSP employee, you will be eligible for medical, dental, vision, 401K, and a variety of other benefits, as well as paid time off including holiday, vacation, and sick/personal time.

About the role

The Clinical Study Assistant (CSA) is responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within clinical projects. Additionally, the CSA provides administrative support to clinical study staff and project managers for assigned studies.

Responsibilities

• Work with study teams and partners to maintain and track relevant activities in CTMS.
• Create and distribute regulatory binders.
• Track study essential documents and ensure completeness of the Trial Master File for assigned clinical studies according to regulations, departmental guidelines, and work instructions.
• Distribute safety documentation to functional groups in support of safety committee meetings (supporting role).
• Create and generate system reports.
• Support study supplies creation, ordering, and distribution to sites (e.g., print protocols, burn DVDs).
• Assist with medical device tracking and ordering if required.
• Adhere to metrics/KPIs outlined in the QOP document.

Requirements

• Minimum of a Bachelor’s degree is preferred.
• Previous clinical research experience is a plus.
• At least 1 year of administrative support experience or equivalent.
• Clinical or medical background is a plus.
• Experience and knowledge working with computer systems (Microsoft Office – Excel, Word, and PowerPoint).