Clinical Study Assistant

Clinical Study Assistant
Kelly Science and Clinical FSP is currently seeking a Clinical Study Assistant (CSA) for a long-term engagement with one of our Global Medical Device clients. This position is remote in eastern time zone. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.
Summary:
CSA is responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects. In addition, administratively support clinical study staff as required. Supports project managers within the assigned clinical studies.
Deliverables:

• Work with Study Teams and partners to maintain and track relevant activities in CTMS.
• Creation/distribution of regulatory binders
• Timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.
• Distribution of safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).
• Creation and generation of system reports.
• Provide support for study supplies creation, ordering and distribution to the sites e.g. print protocols, burn DVDs
• Assist with Medical Device tracking and ordering if required and if applicable.
• Metrics/KPIs:
• Metrics/KPIs governing these services are outlined in the QOP document.

Education and Experience Guidelines:

• Minimum of a Bachelor's Degree is preferred
• Previous clinical research experience a plus.
• Requires previous administrative support experience or equivalent for at least 1 year.
• Clinical/medical background a plus.
• Requires experience and knowledge working with computer systems (Microsoft office - Excel, Word and Power Point).