Clinical Data Coordinator

Quotient Sciences•Miami, FL

21h•Onsite

About The Position

Responsible for data entry associated tasks for assigned studies, including source document retrieval, source data QC, data entry, source document filing, QC of CRF entries, laboratory result tracking, and archiving. This role requires compliance with GCP guidelines and regulations, and provides support to the Clinic and PM teams.

Requirements

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

Responsibilities

Prepares study binders for source document storage.
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 and may reissue queries.
Enters subject data from source documents into client databases according to eCRF completion guidelines/Data Management Plan and study timelines.
Resolves or escalates queries within established timelines.
Identifies source document or EDC database issues and 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 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.
Assists with all other duties as assigned.
Acts as recorder for clinical activities in eSource as required.
Supports clinical and PM staff as assigned.