Data Entry Specialist responsible for entering and managing clinical study data. Collaborating with research coordinators to ensure accurate data entry and compliance with regulations.
Responsibilities
Oversee and manage the data entry from the source document to the case report form(CRF)
Reviews patient records for completeness and accuracy
Meets with sponsor/monitors to review data entry
Serves as a backup to help coordinate and schedule monitoring visits
Serves as a backup to provide support and information to monitors as necessary and as directed by supervisor(s)
Timely resolution of data queries promptly to ensure completeness of CRFs
Assures that data entry remains current for all studies per SOP
Complies with all applicable regulations, guidelines and procedures pertaining to dataloading, EDC and clinical research
Identifies lab facilities used for studies so that lab certifications can be requested for study files
Reviews and utilizes protocols as guides for study activities
Communicates as needed with accounts receivable staff regarding submitted data
Attends meetings and briefings regarding clinical studies as required
Ability to assist in the guidance and training of less experienced staff
Maintains professional demeanor with sponsors, monitors, and auditors
Requirements
High School Diploma, Associate Degree and/or certificate program preferred
Working knowledge of clinical research Electronic Data Capture (EDC) systems
Excellent interpersonal skills to deal effectively with research personnel
Knowledge of medical terminology
Knowledge of ICH GCP, FDA, OHRP, OSHA and HIPAA guidelines pertaining to clinical research
Excellent organizational skills to independently manage workflow
Ability to prioritize quickly and appropriately with minimal guidance
Ability to multi-task
Ability to work independently and function as part of a team
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