US ~ Miami
Clinical Trials Administrator
Clinical Trials 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, specializing 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.
Due to growth and expansion, we have an exciting opportunity for a Clinical Trials Administrator to join the Project Managment Department. As a Clinical Trials Administrator, you will primarily be responsible to provide administrative support for the Project Management group and to lead the IRB activities and communications on allocated projects.
Other tasks and responsibilities will include:
- Assist in production and formatting of various study documentation including, but not limited to informed consent forms, study source sheets, client summaries
- Investigator Site File set up and maintenance
- Set up and filing into client Trial Master Files (electronic and paper)
- Ownership of 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
- Manage the IRB relationship for allocated studies including amendments and administrative letters, study status, and safety reports. Closeout reports and all IRB approvals.
- 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 IRB.
- 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 Salesforce Entry, Revenue Forecasting, and Invoices.
- Assists in any other duties as assigned.
The job may involve the following:
Strict and tight deadlines
Having to juggle a range of tasks/issues simultaneously
Needing to respond to client demands
The successful candidate will have good computer skills including word processing and the use of databases.
Other essential skills and experience are:
High attention to detail
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.