US ~ Miami
Clinical Trial Administrator
Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
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 Responsibilities:
- 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 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.
- Assists with all other duties as assigned.
- Excellent problem solving and organizational skills
- Effective communication skills
- Computer proficiency (Windows environment)
- Minimum Degree qualification or equivalent
- Relevant work experience in a pharmaceutical company/CRO would be an advantage
- Proficient in Information Technology
- Highly organized and efficient
- Ability to communicate effectively; people oriented personality
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.