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Clinical Project Coordinator
6 days ago
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 helpbiotech and pharma customers save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100talented 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 communitythat’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
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
Main tasks and responsibilities
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.
Ongoing clinic query resolution from screening through post discharge following SDV.
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.
Support SBIM (meeting minutes)
Support Trial One UAT activities
The Candidate
Minimum Degree qualification or equivalent
Relevant work experience in a pharmaceutical company/CRO would be an advantage
ApplicationRequirements
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.
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