Clinical Trial Administrator
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
- The Clinical Trials Administrator, is responsible to provide administrative support for the Project Management group and to lead the study review activities and communications on allocated projects
- To comply & adhere to GCP guidelines and regulations as required of this role
Main Tasks and Responsibilites
- Assist in production and formatting of various study documentation including, but not limited to informed consent forms, study source sheets, client summaries
- Set up and maintain Study Files
- Set up and filing into client Trial Master Study Files (electronic and paper)
- Maintain delegation logs – work with internal departments to ensure the delegation logs are current. Update new-terminated employees
- File Note control and filing
- Ensuring all the regulatory documents are archive ready
- Support the relationship with the study review board. Upload administrative letters, study status, and other documents as provided by the study team
- Process Spanish documents for regulatory submission, and notify screening when approvals arrive
- Work with the recruitment and marketing team to ensure advertising for studies is prepared and submitted to the study review board
- Training logs – work with internal departments to ensure training of those listed on delegations logs is current
- Notify staff when updated documents are posted in a secure file
- Support project management team on Focal Point Entry, Revenue Forecasting, and Invoices
- Assist Project Managers with close out activities including archiving and reconciliations of budgets
Assist with the hosting and support of sponsor monitors during site visits and with related action items
- Associate’s Degree or higher
- Relevant work experience in a pharmaceutical company/CRO would be an advantage
- Computer literate, proficient in Microsoft Windows
- Proficient in Information Technology
- Highly organized and efficient
- Ability to communicate effectively; people oriented personality
The job may involve the following:
- Very high concentration of work
- Strict and tight deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
In return you will receive a competitive salary, excellent training and development, as well as an exciting career within a fast paced and dynamic business.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at email@example.com.