Data Specialist (Full Time/Per Diem)
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 save precious time and money in getting drugs to patients.
As a growing and successful business, 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, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
The Data Entry Coordinator is 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.
Main tasks and responsibilities will include:
- Prepares study binders for source document storage as instructed by Data Entry Manager.
- 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 and re-train staff as appropriate
- 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 Data Entry 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 Data Entry Manager
- Greets monitor visitors upon arrival/registration and ensures study files are returned to Records Room at the end of each day/visit
- Assists with all other duties as assigned
- 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
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
In return you will receive a competitive salary, excellent training and development, as well as an exciting career within a fast paced and dynamic business.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at firstname.lastname@example.org.