Clinical Data Coordinator (Per Diem)

Quotient Sciences : Molecule to Cure. Fast.

We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform, Translational Pharmaceutics , shortens timelines by 9-12 months on average.

Arcinova , our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling-streamlining early development from candidate selection to proof of concept.

Why join us?

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.

The Role

Join our team in Miami as a Clinical Data Coordinator - Per Diem Role (24-32 Hours Weekly)

We are looking for a Clinical Data Coordinator to join our team in Miami. You will be responsible for the following data entry associated tasks for assigned studies : source document retrieval, source data QC, data entry, source document filing, QC of CRF entries, laboratory result tracking, and archiving.

Complying and adhering to GCP guidelines and regulations as required of this role. Providing support to the Clinic and Project Management teams.

Main tasks and responsibilities

• Prepares study binders for source document storage as instructed by Project Manager and / or Clinical Data Supervisor.
• 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 Manager
• 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 Manager
• Assists with all other duties as assigned
• Acts as recorder for clinical activities in eSource as required
• Supports clinical and PM staff as assigned

The Candidate

Application Requirements

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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