Clinical Research Assistant

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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. The Research Assistant works collaboratively with the clinical team to facilitate study activities in accordance with Good Clinical Practice (GCP) guidelines, study protocols, and institutional policies.

Key Responsibilities

Study Support & Coordination

• 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.

Data & Documentation

• 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.

Participant Interaction

• 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.

Regulatory & Compliance

• 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
• 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.