Clinical Research Assistant

Position Summary

The Research Assistant supports the execution of clinical research studies by performing administrative, technical, and participant-focused tasks under the supervision of the Clinical Research Coordinator and Principal Investigator. This role plays a critical part in ensuring high-quality data collection, regulatory compliance, and participant safety.

Key Responsibilities

• Assist in preparing study materials, source documents, and regulatory binders.
• Support participant screening, recruitment, and scheduling in accordance with study protocols.
• Maintain accurate participant logs and assist in tracking enrollment progress.
• Ensure study areas, supplies, and equipment are organized and ready for study visits.
• Accurately record data from source documents into electronic case report forms (eCRFs) or databases.
• Maintain confidentiality and integrity of participant data in compliance with HIPAA and institutional standards.
• Assist in resolving data queries and ensuring timely data entry.
• Support document management, filing, and archiving according to regulatory requirements.
• Greet and assist study participants during visits to ensure a positive experience.
• Prepare consent materials and provide administrative support during the informed consent process.
• Escort participants to appropriate testing areas and assist clinical staff with noninvasive study procedures as directed.
• Follow Good Clinical Practice (GCP) and institutional policies at all times.
• Support compliance with IRB, sponsor, and regulatory agency requirements.
• Participate in site audits, monitoring visits, and internal quality reviews as needed.
• Work closely with Clinical Research Coordinators, Principal Investigators, and site teams to ensure timely completion of study milestones.
• Participate in team meetings, training, and continuing education to stay current with study and regulatory updates.
• Contribute to process improvements and operational efficiency initiatives.

Qualifications

• Associate or bachelor’s degree in a health sciences, biology, psychology, or related field preferred.
• Previous experience in healthcare or research setting is strongly preferred.
• Familiarity with clinical trials, GCP, HIPAA, and human subjects research regulations are desirable.
• Strong organizational, communication, and time management skills.
• Ability to work accurately in a fast-paced environment with strong attention to detail.
• Proficiency with Microsoft Office and data entry systems; experience with EDC or CTMS systems a plus.

Core Competencies

• Accuracy and Attention to Detail
• Professionalism and Confidentiality
• Team Collaboration
• Adaptability and Initiative
• Ethical Conduct and Compliance Awareness

Physical Requirements

• Ability to sit or stand for extended periods.
• May require occasional lifting of study materials (up to 25 lbs).
• Ability to interact with participants and staff in clinical and office settings.