Clinical Data Coordinator (Per-Diem)

Quotient Sciences; Miami (FL); On-site; USD 32,000 - 42,000; Full time

Job summary

Quotient Sciences is seeking a detail-oriented Data Entry Associate to support assigned studies by retrieving source documents, performing data entry and QC checks, and archiving records. You will ensure compliance with GCP and collaborate with Clinic and PM teams to meet timelines.

Candidate should have a High School Diploma or equivalent, strong data entry skills, and proficiency with MS Word, Excel, and Office Suite. The role may involve working outside normal hours to meet project needs.

Qualifications

• High School Diploma or equivalent required.
• Data input and/or QC review experience preferred.
• Strong communication and organizational skills required.
• Proficiency with Microsoft Word, Excel and Office Suite.
• Able to work under tight deadlines and manage multiple tasks.

Responsibilities

• Perform data entry from source documents into client databases in accordance with study guidelines and timelines.
• QC of CRF entries and source documents; ensure accuracy and resolve discrepancies.
• Track laboratory results and archive study documents per SOPs.

Skills

Effective communication

Deadline oriented

Team interaction

Self-directed

Attention to detail

Ability to read protocols

Education

High School Diploma or equivalent

Tools

Microsoft Word

Excel

Office Suite

Job description

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

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