Clinical Trial Administrator

Quotient Sciences: Molecule to Cure. Fast. Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing.

Our proprietary and disruptive platform - "Translational Pharmaceutics " - integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times.

Why join us:

Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast.

The Role

To provide administrative support for the Project Management group To comply & adhere to GXP guidelines and regulations as required of this role.

This is a 12 month fixed term contract

Main tasks and responsibilities

• Assist in production and formatting of various study documentation including, but not limited to study worksheets, subject lists and client summaries
• Investigator Site File and eTMF set up and maintenance
• Complete and initiate TMF QC (paper and electronic)
• Set up and filing into client Trial Master Files (electronic or paper) where requested by clients
• Maintenance of delegation logs
• File Note control and filing
• Breakdown of files ready for archiving
• Provide support to monitoring visits as needed
• Study specific document issue and recall e.g. protocols, informed consent documents, blinding plans, risk management plans
• Set up of the clinical study folder, dispensary study folder, laboratory study folder and recruitment study folder

Additional Tasks/responsibilities

Administrative support to other groups within Quotient Sciences as required such as reception cover, assist with ethics submission documentation, SOP administration etc. Assist in the delivery of studies within the clinic by completing cross training requirements and performing procedures which include but are not limited to vital signs, ECGs, blood sampling and dosing where applicable.

Qualifications and experience required for competent performance

• Minimum GCSE/ 'O' Level English Language or equivalent
• Good computer skills including word processing and the use of databases

Application Requirements

When applying for a position with Quotient Sciences to be able to work in our organization 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 are 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 organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, color, 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.