What are the responsibilities and job description for the Clinical Trial Administrator position at Quotient Sciences?
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
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.
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
- 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
- Assist in the preparation and formatting of study documentation, including informed consent forms, source documents, and client deliverables.
- Establish and maintain study files, including Trial Master Files (TMF) in both electronic and paper formats.
- Maintain delegation logs by coordinating with internal teams to ensure accuracy and timely updates for new and terminated staff.
- Maintain training logs and ensure training compliance for all personnel listed on delegation logs.
- Manage file note control, including creation, review, and filing.
- Ensure all regulatory documentation is audit-ready and compliant with archiving requirements.
- Support study review board submissions by uploading administrative documents, study updates, and required correspondence.
- Process Spanish regulatory documents and communicate approvals to the screening team.
- Notify staff of updated or newly released documents via secure file systems.
- Support the Project Management team with PSA activities, revenue forecasting, and invoicing.
- Assist with study closeout activities, including budget reconciliation and archiving.
- Maintain and perform quality control (QC) of the volunteer clinical RSVP database.
- Manage laboratory requisitions and collaborate with Data Management to support query resolution.
- Support eSource User Acceptance Testing (UAT) activities.
- Assist with the hosting and support of sponsor monitors during site visits and with related action items
- 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
- Minimum Degree qualification or equivalent
- 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
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.