US ~ Miami
Data Entry Coordinator
Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
- 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:
- Prepares study binders for source documents as instructed by Data Entry Manager.
- Performs QC of all source documents, paper and electronic.
- Identifies discrepancies in source documents and works with staff for corrections or explanations.
- Evaluates query responses in eSource. May reissue query as necessary and re-train staff as appropriate.
- Completes CRFs ensuring data entry timelines are met.
- 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 of 100% of completed CRF entries.
- Performs timely lab result tracking as assigned by the Data Entry Manager.
- Responsible for the accurate and timely filing of all study-related documents.
- Ensures that study binders are ready for monitoring visits.
- Provides supervisor a daily update of status for all data entry associated tasks for assigned studies.
- Reports protocol deviations promptly.
- Archives completed study according to established SOPs and Work Instructions
- Performs unscheduled accounting and data QA for lab data transfers as assigned by Data Entry Manager.
- Greets visitors and registers their arrival and departure in the Visitor Log located in the reception area.
- Assists with all other duties as assigned.
- Excellent problem solving and organizational skills
- Effective communication skills
- Computer proficiency (Windows environment)
- High School Diploma or equivalent
- 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