Data Entry Specialist

IQVIA • Fairfax, VA

3d • Remote

About The Position

The Data Entry Specialist performs data entry functions for case report forms by entering clinical study data collected by the research team into the Electronic Data Capture (EDC) system and resolving data queries. Under the direction and supervision of the Director of Data Management, the role works closely with research coordinators in support of ongoing clinical studies. This position is fully remote.

Requirements

• High school diploma required.
• Working knowledge of clinical research Electronic Data Capture (EDC) systems.
• Excellent interpersonal skills for dealing 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 multitask.
• Ability to work independently and function as part of a team.
• Clear and concise verbal and written communication skills.

Nice To Haves

• Associate degree and/or certificate program preferred.

Responsibilities

• Oversee and manage data entry from source documents to case report forms (CRFs).
• Review patient records for completeness and accuracy.
• Meet with sponsors and monitors to review data entry.
• Serve as a backup to help coordinate and schedule monitoring visits and to provide support and information to monitors as directed by supervisors.
• Resolve data queries promptly to ensure CRFs are complete.
• Keep data entry current for all studies in accordance with SOPs.
• Comply with applicable regulations, guidelines, and procedures relating to data loading, EDC, and clinical research.
• Identify laboratory facilities used for studies so laboratory certifications can be requested for study files.
• Review and use protocols as guides for study activities.
• Communicate as needed with accounts receivable staff regarding submitted data.
• Attend meetings and briefings regarding clinical studies as required.
• Assist in guiding and training less experienced staff.
• Maintain a positive attitude with the research team and a professional demeanor with sponsors, monitors, and auditors.
• Remain current with all required training.
• Perform other duties as assigned.

Benefits

• A range of health and welfare and/or other benefits may be offered, depending on the position.

What This Job Offers

• Job Type: Full-time
• Education Level: High school or GED