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Clinical Project Coordinator

Quotient Sciences

Quotient Sciences

Miami, FL, USA
Posted on Monday, June 10, 2024

Clinical Project Coordinator

Miami, FL, USA Req #197
06 June 2024
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 help biotech and pharma customers save precious time and money in getting drugs to patients.

As a growing and successful business, we employ more than 1,100 talented 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 community that’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.
  • 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.
  • 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

Application Requirements

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

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

Other details

  • Pay Type Salary