Clinical Data 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

Effective communication skills
Computer proficiency (Microsoft Word, Excel and Office Suite products)
High School Diploma or equivalent
Data input and/or QC review experience
Able to assume increasing levels of responsibility and perform effectively
Able to plan, coordinate, organize, and prioritize to meet deadlines
Able to interact successfully with team members and study participants
Self-directed - able to perform with minimal supervision
Thorough in task completion- attention to detail
Able to read and understand protocols
Must be aged 18 years or over
Must not have been debarred by the FDA

Responsibilities

Responsible for the following data entry associated tasks for their assigned studies: source document retrieval, source data QC, data entry, source document filing, QC of CRF entries, laboratory result tracking, and archiving
To comply & adhere to GCP guidelines and regulations as required of this role.
To provide support to the Clinic and PM teams
Prepares study binders for source document storage as instructed by Project Management
Supports and performs QC of all source documents, paper and electronic
Identifies discrepancies in source documents and works with clinical staff for corrections or explanations
Evaluates query responses in eSource. May reissue query as necessary
Enters subject data from source documents into client databases in accordance with the eCRF completion guidelines/Data Management Plan and study timelines
Resolves or escalates queries within the established timelines
Identifies source document or EDC database issues and promptly communicates them to the Project Management team
Enters, tracks, and performs QC for Adverse Events and Concomitant Medications
Performs Adverse Event and Concomitant Medication Count (source vs. eCRF).
Performs QC for 100% of completed CRF entries
Performs timely lab result tracking
Responsible for the accurate and timely filing of all study-related documents
Ensures that volunteer source document files/binders are ready for monitoring visits
Provides supervisor a daily update of status for all data entry associated tasks for assigned studies
Maintains record of entry/QC in tracker spreadsheet
Reports protocol deviations promptly
Archives completed study documents according to established SOPs and Work Instructions
Accounts for unscheduled lab reports and performs QC/QA for lab data transfer files as assigned by Project Management
Assists with all other duties as assigned
Acts as recorder for clinical activities in eSource as required
Supports clinical and PM staff as assigned