Clinical Data Coordinator

3 days ago

Miami FL United States Quotient Sciences Limited Full time

Posted Thursday 19 September 2024 at 10:00

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.

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

  • 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.

Main tasks and responsibilities

  • 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.
  • 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.
  • 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.

The Candidate

  • 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.

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.

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