About the Role:
What You’ll Do in Your New Role:

• Manages and conducts the day-to-day study activities in accordance with the protocol, applicable regulations, and GCP requirements
• Identifies and explains key protocol elements and performs study tasks under direct supervision
• Explains basic elements of subject safety, including reasoning behind use of an Institutional Review Board/Independent Ethics Committee, study activity documentation, and event reporting requirements
• Demonstrates subject protection under direct supervision
• Explains the investigational products development process and identifies key regulations to control this process
• Explains and performs study operational activities in compliance with Good Clinical Practice (GCP)
• Explains and performs non-GCP related study management activities
• Explains how to document data according to Attributable, Legible, Contemporaneous, Original, Accurate and Complete (ALCOA-C) principles
• Explains the importance of professional conduct and describes leadership principles that impact the effective operation of a study site
• Explains the variety of communication channels, roles, and relationship, and outlets for study results that impact the conduct of clinical research
• Responsible for the collection and compilation of data
• Participates in appropriate and proper consenting procedures
• Supports the safety and privacy of clinical research subjects
• Coordinates study procedures with clinical treatment and follow up care as appropriate
• Screens, recruits, and enrolls study subjects
• Maintains study source documents
• Reports adverse events properly and promptly
• Creates, completes, maintains, and organizes all study documents accurately and promptly
• Accounts for study materials, to include participant lists, visit logs, regulatory binders, case report forms, laboratory supplies, participation incentives, and investigational product
• Conducts and documents visit and protocol-specific procedures according to approved protocol and operating procedures of the clinical site
• Requests or acquires equipment and supplies as necessary
• Prepares progress reports and presentations for regular review and oversight
• Leads clinical site training and certification
• Works under direct or limited supervision of PM and PI
• Performs other duties and tasks as required

Required Qualifications:

• 7+ years of clinical research coordination experience or related experience AND a HS Diploma

OR

• 4+ years of clinical research coordination experience or related experience AND an Associate Degree

OR

• 2+ years of clinical research coordination experience or related experience AND a Bachelors Degree
• Functional knowledge of Good Clinical Practice (GCP) and the International Council for Harmonization (ICH) E6 guidelines
• Expert knowledge of organizational, local, and national government research regulations
• Certification in Human Subjects Protection/CITI Training (must be obtained within 30 days of hire)
• Fluent in Ukrainian and English language to support technical medical research discussions

Desired Qualifications:

• Certified Clinical Research Coordinator (CCRC)

About the Company: