Clinical Project Coordinator

Quotient Sciences•Miami, FL

About The Position

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. 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.

Requirements

Minimum Degree qualification or equivalent
Must be aged 18 years or over
Must not have been debarred by the FDA

Nice To Haves

Relevant work experience in a pharmaceutical company/CRO would be an advantage

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.
SBIM (meeting minutes).
Trial One UAT activities.