Clinical Research Assistant: Trials Coordination & Data

Epic Medical Research, LLC.; Chickasha (OK); Sur place; USD 42 000 - 66 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Attention to detail

Communication skills

Interpersonal skills

FDA/ICH-GCP/IRB familiarity

Formation

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

Description du poste

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.