Data Entry Specialist

Role Description

Under the direction and supervision of the Director of Data Management, this position is responsible for performing all data entry functions as they relate to the completion of case report forms, by entering study data collected by the research team into the Electronic Data Capture (EDC) system. Data entry personnel will also resolve all data queries. The position works closely with the research coordinators in support of all ongoing clinical studies.

• 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 data loading, 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
• Ability to maintain a positive attitude with the research team
• Maintain professional demeanor with sponsors, monitors, and auditors
• Remains current with all required training
• Performs other duties as assigned

Qualifications

• 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
• Clear and concise verbal and written communications

Requirements

• High School Diploma, Associate Degree and/or certificate program preferred

Benefits

• The potential base pay range for this role, when annualized, is $25,900.00 - $91,300.00.
• The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).
• Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.