What are the responsibilities and job description for the Clinical Project Coordinator 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
- To support project management in the completion of allocated projects to the agreed standards of quality, to agreed timelines and within cost budget To comply & adhere to GCP guidelines and regulations as required of this role
- Assist in production and formatting of study documentation e.g. informed consent forms, training materials, file notes, laboratory manuals etc.
- Support set up of vendors.
- Internal risk-based monitoring following first dosing to ensure all study documentation is working effectively.
- Assist with internal data generation such as recruitment and subject status updates, adverse event summaries etc.
- Set up and host Sponsor monitoring visits
- CRA Trial One Training
- Ensure monitoring visit action items are addressed
- Assist Project Managers with close out activities e.g. archiving, reconciliation.
- Manage data query resolution.
- Ongoing clinic query resolution from screening through post discharge following SDV.
- Answer queries during database cleaning.
- Action process improvement initiatives as allocated
- Work with the study team to ensure the Investigator Site File and Trial Master Files are maintained and perform periodic QC of TMF (as per DOC-00433 Trial Master File).
- General support to the Commercial and Project Management groups as needed to win and deliver business
- Support PM Team on Focal Point set up and invoicing.
- Support Database close and lock activities.
- SBIM (meeting minutes).
- Trial One UAT activities.
- Minimum Degree qualification or equivalent
- Relevant work experience in a pharmaceutical company/CRO would be an advantage
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.