QC Specialist

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. 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.

Requirements

Minimum 2 years’ relevant experience in a clinical environment or equivalent experience in another role
Proficient in the use of Microsoft Office packages including Word, Excel...etc.
Attention to detail and organizational skills required
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
Able to read and understand protocols
Must be aged 18 years or over
Must not have been debarred by the FDA

Responsibilities

Supports Clinical Manager to ensure data integrity during study set up and data collection
Timely reviews source data collected for data integrity and compliance with Good Documentation Practices and relevant SOPs
Reconciles source data collected on paper with eSource comments and entries
Works with the clinic and project management departments to ensure that qc and query resolution timelines are being met
Works with Clinical Manager to implement measures to uphold data integrity
Complies & adheres to GCP guidelines and regulations as required of this role.
Ensures study data is collected to a high quality in accordance with Good Clinical Practice (GCP) standards.
Ensures subject safety at all times
Serves as support for Clinical Manager to ensure studies are set up for successful and high-quality data collection
Understands clinical protocols and requirements for data collection
Performs real-time QC checks on critical data as assigned by Clinical Manager
Ensures proper QC checks are performed on all clinical data for data integrity, particularly looking for incomplete or implausible data
Resolves queries as per scope and coordinates resolution of queries requiring other clinical parties
Ensures queries are addressed and resolved by the appropriate parties; assists as needed
Identifies discrepancies in source documentation and works with clinical staff for corrections and/or explanations.
Promptly reports any evidence or suspicion of fraudulent data collection or documentation
Evaluates query responses in eSource. May reissue query as necessary and re-train staff as appropriate
Reports/records protocol deviations encountered during review of clinical data
Ensures paper sources are transcribed appropriately and timely into the eSource capture system
Assists with QC of study activity schedules against the eSource build during study start up
Prepares the initial template for lab tracking and ensures lab tracking is up to date.
Works collaboratively with the Clinical Leads during study start up to plans for high quality data collection for all studies
Works with the Project Management team to ensure the timelines are being met for QC and query resolution
Assists with retrospective review of clinical data, e.g. in quality deviation investigations, upcoming audits, etc.
Assists with activities to support validation of clinical systems
Acts as a recorder for clinical activities in eSource as required
Performs clinical activities according to scope of practice