Responsibilities
- Accurately enter clinical trial data into Electronic Data Capture (EDC) systems in compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.
- Perform validation and quality checks to ensure data completeness and accuracy.
- Work collaboratively with clinical research coordinators and site staff to resolve discrepancies.
- Generate data reports and summaries for site and study team review as needed.
- Keep current on all study-related documents and database/system updates.
- Follow all Standard Operating Procedures (SOPs) and suggest improvements to optimize workflows.
Requirements
- Medical background (degree or relevant professional experience) is required.
- Prior data entry experience in clinical research or healthcare is highly preferred.
- Proficiency with Microsoft Office Suite (Word, Excel, Outlook).
- Excellent attention to detail and high degree of accuracy.
- Ability to work under tight deadlines in a regulated environment.
- Effective communication skills and a collaborative spirit.
Nice to Have
- Experience with EDC platforms such as Medidata RAVE, REDCap, or similar systems is highly preferred.
- Familiarity with clinical trial processes and medical terminology is a plus.
Additional Information
- Availability during standard business hours in Pacific (PST), Central (CST), or Eastern (EST) time zones.
- Maintain strict confidentiality and security of all clinical trial data.
- Complete all study-required trainings as instructed by the clinical research site team.
