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.
Summary Of Job Purpose
Drive project success by supporting the delivery of assigned studies to the highest standards of quality, on time and within budget. Uphold GCP guidelines and regulatory requirements, ensuring every project meets our commitment to excellence and compliance.
What You’ll Bring
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.
Summary Of Job Purpose
Drive project success by supporting the delivery of assigned studies to the highest standards of quality, on time and within budget. Uphold GCP guidelines and regulatory requirements, ensuring every project meets our commitment to excellence and compliance.
What You’ll Bring
- Minimum degree qualification or equivalent.
- Relevant experience in a pharmaceutical company or CRO is an advantage.
- Assist in the creation and formatting of essential study documentation, including informed consent forms, training materials, file notes, and laboratory manuals.
- Support the set-up of vendors to enable smooth project delivery.
- Conduct internal risk-based monitoring after first dosing to ensure all study documentation is functioning as intended.
- Generate and manage internal data, such as recruitment and subject status updates, and adverse event summaries.
- Organise and host Sponsor monitoring visits, ensuring a professional and collaborative experience.
- Complete CRA Trial One Training and address action items from monitoring visits.
- Support Project Managers with close-out activities, including archiving and reconciliation.
- Manage data query resolution and ongoing clinic queries from screening through to post-discharge following SDV.
- Respond to queries during database cleaning to maintain data integrity.
- Implement process improvement initiatives as allocated.
- Work closely with the study team to maintain the Investigator Site File and Trial Master File, performing periodic quality checks in line with DOC-00433.
- Provide general support to Commercial and Project Management teams to help win and deliver business.
- Assist the PM Team with Focal Point set-up and invoicing.
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.