Clinical Research Assistant

Epic Medical Research, LLC.; Sun City (AZ); On-site; USD 52,000 - 76,000; Full time

Job summary

Epic Medical Research, LLC. is seeking a Clinical Research Coordinator to support the study team from start-up to close-out. You will assist in recruitment, consent, coordination, data collection, and regulatory compliance to keep trials running smoothly.

The role requires a Bachelor's degree in Life Science or Public Health, strong documentation skills, and excellent communication. FDA/ICH-GCP familiarity is preferred; on-site work in Sun City, AZ may be required.

Qualifications

• Bachelor's degree in Life Science, Applied Life Science, or Public Health.
• Strong attention to detail and documentation skills.
• Excellent interpersonal and communication skills.
• Familiarity with FDA, ICH-GCP, and IRB requirements preferred.

Responsibilities

• Support the clinical research team across subject recruitment, informed consent, study coordination, data collection, regulatory compliance, and sponsor communications.
• Identify potential research participants through medical records and physician referrals.
• Conduct pre-screening interviews and determine study eligibility based on protocol requirements.
• Schedule study visits and maintain ongoing participant communication.
• Explain study procedures, risks, benefits, and participant responsibilities; conduct informed consent discussions.
• Maintain participant engagement, safety, and confidentiality throughout the study.
• Coordinate protocol-required study visits and collect source data, medical histories, vital signs, and study-related information.
• Maintain accurate source documentation and ensure protocol compliance.
• Maintain regulatory binders and essential study documents.
• Enter and review study data in Electronic Data Capture (EDC) systems and resolve data queries.
• Ensure compliance with FDA, ICH-GCP, IRB, and sponsor requirements.
• Coordinate monitoring visits, audits, and sponsor communications; assist investigators with study reports and documentation.
• Participate in study start-up, training, and close-out activities.

Skills

Attention to detail

Documentation skills

Interpersonal communication

Regulatory knowledge

Education

Bachelor's Degree in Life Science / Public Health

Job description

Support the clinical research team across subject recruitment, informed consent, study coordination, data collection, regulatory compliance, and sponsor communications to keep trials running smoothly from start-up to close-out.

Key Duties & Responsibilities

• Identify potential research participants through medical records and physician referrals.
• Conduct pre-screening interviews and determine study eligibility based on protocol requirements.
• Schedule study visits and maintain ongoing participant communication.
• Explain study procedures, risks, benefits, and participant responsibilities, and conduct informed consent discussions.
• Maintain participant engagement, safety, and confidentiality throughout the study.
• Coordinate protocol-required study visits and collect source data, medical histories, vital signs, and study-related information.
• Maintain accurate source documentation and ensure protocol compliance.
• Maintain regulatory binders and essential study documents.
• Enter and review study data in Electronic Data Capture (EDC) systems and resolve data queries.
• Ensure compliance with FDA, ICH-GCP, IRB, and sponsor requirements.
• Coordinate monitoring visits, audits, and sponsor communications; assist investigators with study reports and documentation.
• Participate in study start-up, training, and close-out activities.

Requirements

• Bachelor's Degree in Life Science, Applied Life Science, or Public Health
• Strong attention to detail and documentation skills
• Excellent interpersonal and communication skills
• Familiarity with FDA, ICH-GCP, and IRB requirements preferred