Onsite Data Entry Specialist

Posted last week

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About the role

  • 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

Benefits

  • Health insurance
  • Retirement plans
  • Paid time off
  • Professional development opportunities

Job title

Data Entry Specialist

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

High School Diploma

Location requirements

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