Clinical Trial Administrator

3 days ago

Miami FL United States Quotient Sciences Limited Full time

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 help biotech and pharma customers save precious time and money in getting drugs to patients.

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 that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

The Role

  • The Clinical Trial Administrator is responsible for providing administrative support for the Project Management group and leading 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, and client summaries.
  • Set up and maintain Study Files.
  • Set up and file into client Study Files (electronic and paper).
  • Maintain delegation logs – work with internal departments to ensure the delegation logs are current. Update for new and terminated employees.
  • File Note control and filing.
  • Ensure 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 delegation logs is current.
  • Notify staff when updated documents are posted in a secure file.
  • Support the 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.

The Candidate

  • 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.

Application Requirements
When applying for a position with Quotient Sciences, you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred, then your application will be automatically declined.

Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.

Specifically, we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status, or any other characteristic prohibited by federal, state and/or local laws.

This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.

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