Data Entry CoordinatorFull Time

Quotient Sciences: Molecule to Cure. Fast.

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.

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

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

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

Job Demands

The Job May Involve The Following

Very high concentration of work

Strict and tight deadlines

Having to juggle a range of tasks/issues simultaneously

Working in a hazardous environment with high requirement to follow safety procedures

Working outside normal working hours

Needing to respond to client demands

The Candidate

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

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.

Pay: $24.00 - $29.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance

Work Location: In person