Clinical Study Assistant Remote in New Brunswick, NJ, US • Posted 6 days ago • Updated 7 hours ago Contract W2 On-site Motion Recruitment Partners, LLC Fitment Dice Job Match Score™ 🔢 Crunching numbers... Job Details Skills Science Filing Management Clinical Trial Management System Documentation Distribution Medical Devices KPI Clinical Research Administrative Support Microsoft Excel Microsoft PowerPoint Science Filing Management Clinical Trial Management System Documentation Distribution Medical Devices KPI Clinical Research Administrative Support Microsoft Excel Microsoft PowerPoint Summary 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). Employers have access to artificial intelligence language tools ("AI") that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id:

10105282

Position Id:

885247 Posted 6 days ago Company Info About Motion Recruitment Partners, LLC Motion Recruitment delivers IT Talent Solutions for Contract, Direct Hire, Managed Solutions and Statement of Work to all of North America from our 21 delivery centers. Our high-touch, specialized, team-based recruitment model's success is proven through our exemplary track record in filling the most challenging IT positions for startup and enterprise clients alike. Our hyper-specialized tech focus results in a truly consultative approach for both our clients and candidates, within our recruiting areas of expertise: Software, Mobile, Data, Infrastructure, Cybersecurity, Product + UX and Functional. Motion also delivers IT Consulting Solutions through the Motion Consulting Group (MCG) that create true digital transformation for IT projects in Agile Development & Coaching, DevOps & DevSecOps Solutions, and Managed Services for IT Operations. We're also the proud creators of Tech in Motion and the Timmy Awards, our North American community platform, events series and award program that connects over 250,000 tech enthusiasts to meet, learn, and innovate.