Clinical Research Data Assistant

Clinical Research Data Assistant

This will be an in-person position in South Miami, Florida

Position Summary

The Clinical Research Data Assistant provides administrative, data management, and study support services for clinical research studies. This position is responsible for sponsor system data entry, study reporting, document management, regulatory support, and research communications.

The Clinical Research Data Assistant works closely with Clinical Research Coordinators, investigators, sponsors, and the regulatory team to ensure accurate, timely, and compliant study documentation and reporting.

Essential Responsibilities

Data Management

• Enter study data into sponsor electronic data capture (EDC) systems.
• Transcribe source documentation into sponsor systems accurately and timely.
• Review entered data for completeness and accuracy.
• Resolve basic data discrepancies and escalate complex issues.
• Maintain study tracking logs and databases.

Sponsor Systems Management

• Maintain user access and system tracking documentation.
• Upload required documents into sponsor portals.
• Monitor sponsor system notifications and alerts.
• Support completion of sponsor-required documentation.

Screening, Enrollment, and Study Reporting

• Prepare routine reports on screening, enrollment, randomization, and retention metrics.
• Track recruitment and enrollment performance.
• Maintain study enrollment dashboards and tracking tools.
• Generate reports for site leadership and study teams.

Regulatory and Document Support

• Route study documents for review and signature.
• Assist with collection of regulatory documents.
• Maintain electronic and paper study files.
• Support regulatory filing activities.
• Assist with investigator and staff training documentation.

Communication Management

• Manage study email inboxes.
• Route sponsor communications to appropriate team members.
• Track action items from sponsor correspondence.
• Assist with scheduling sponsor meetings and study-related calls.

Coordinator and Site Support

• Provide administrative support to Clinical Research Coordinators and investigators.
• Assist with study start-up documentation.
• Support study close-out activities.
• Assist with preparation for sponsor monitoring visits, audits, and inspections.

Quality and Compliance

• Maintain confidentiality of participant information.
• Ensure data accuracy and completeness.
• Follow Good Clinical Practice (GCP), sponsor requirements, and site SOPs.
• Participate in quality improvement initiatives.

Qualifications

Education

• High School Diploma required.
• Associate's degree or Bachelor's degree preferred.

Experience

• Previous healthcare, data entry, administrative, research, or regulatory experience preferred.
• Experience with electronic systems and databases preferred.

Knowledge, Skills, and Abilities

• Exceptional attention to detail.
• Strong data entry and computer skills.
• Strong written and verbal communication skills.
• Ability to manage multiple deadlines.
• Strong organizational skills.
• Proficiency in Microsoft Office applications, particularly Excel.
• Ability to learn sponsor systems, CTMS, eSource, and eRegulatory platforms.

Physical Requirements

• Ability to perform prolonged computer-based work.
• Ability to review detailed documentation for extended periods.
• Ability to occasionally lift and move files or supplies up to 15 pounds.