About Ascendion
About Ascendion
Ascendion is a full-service digital engineering solutions company. We make and manage software platforms and products that power growth and deliver captivating experiences to consumers and employees. Our engineering, cloud, data, experience design, and talent solution capabilities accelerate transformation and impact for enterprise clients. Headquartered in New Jersey, our workforce of 6,000+ Ascenders delivers solutions from around the globe. Ascendion is built differently to engineer the next.
Ascendion | Engineering to elevate life
We have a culture built on opportunity, inclusion, and a spirit of partnership. Come, change the world with us:
- Build the coolest tech for the world’s leading brands
- Solve complex problems - and learn new skills
- Experience the power of transforming digital engineering for Fortune 500 clients
- Master your craft with leading training programs and hands-on experience
Experience a community of change makers!
Join a culture of high-performing innovators with endless ideas and a passion for tech. Our culture is the fabric of our company, and it is what makes us unique and diverse. The way we share ideas, learning, experiences, successes, and joy allows everyone to be their best at Ascendion.
About the Project:
Title: Clinical Study Administrator (CSA II)
- Provide support to the clinical study staff within the Clinical R&D COE, as well as foster strong, productive relationships with colleagues within the Clinical R&D COE organization. Responsible for processing, tracking, and filing study documents, and managing 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.
Clinical Administration Tasks:
- Under general supervision, accountable for the 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.
- Creation/distribution of regulatory binders & the wet-ink signed documents binder
- Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File). Respond to problems and assists in implementing corrective and preventive actions.
- Assist in providing internal communication of important clinical data and events.
- Support ongoing use of CTMS by maintaining and tracking relevant activities.
- Provide safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).
Other Administrative Tasks
- May be asked to provide support for study supplies creation, ordering and distribution to the sites e.g. print protocols, burn DVDs
- May be asked to assist with Device tracking and ordering if required and if applicable.
- Assistance with logistics for Investigator meetings/expert panel meetings
- Assistance with distribution of newsletter (create mailing list from CTMS and routing for internal approval)
- Participates in process improvement activities related to CTMS/v-TMF within the department.
Position Information
Locations:Around the USA
This position is eligible for commissions in accordance with the terms of the Company’s plan. Commissions for this position are estimated to be based on individual performance. Additionally, this role is also eligible for a bonus based on the achievement of mutually agreed KRAs.
Want to change the world? Let us know.
Tell us about your experiences, education, and ambitions. Bring your knowledge, unique viewpoint, and creativity to the table. Let’s talk!