Clinical Research Assistant

Epic Medical Research, LLC.; Chickasha (OK); On-site; USD 42,000 - 66,000; Full time

Job summary

Epic Medical Research, LLC. is seeking a dedicated clinical research professional to support the team from start-up to close-out, coordinating participant recruitment, informed consent, data collection, and regulatory compliance.

You will work with investigators to ensure FDA, ICH-GCP and IRB requirements are met, maintain study documentation, and maintain sponsor communications as trials progress.

Qualifications

• Strong attention to detail and documentation skills.
• Excellent interpersonal and communication skills.
• Familiarity with FDA, ICH-GCP, and IRB requirements preferred.

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 regulatory binders and essential study documents.
• Enter and review study data in 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

Communication skills

Interpersonal skills

FDA/ICH-GCP/IRB familiarity

Education

Bachelor's Degree in Life Science, Applied Life Science, or 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