Medical Monitor

Culmen International is looking for a Medical Monitor to work in an inpatient hospital in Kyiv, Ukraine, supporting clinical studies focused on wound infections.

The Clinical Research Coordinator will interact with patients, the healthcare team, research staff, and local and national regulatory bodies to ensure the efficient and ethical execution of all study-related activities, from initiation to completion.

• →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

• 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

• Certified Clinical Research Coordinator (CCRC)

Culmen International is committed to enhancing international safety and security, strengthening homeland defense, improving global health and humanitarian programs, and optimizing government operations.  With experience in over 140 countries, we help our customers to accomplish critical missions in challenging environments worldwide.

To learn more about Culmen International, please visit www.culmen.com

At Culmen International we are committed to creating, promoting, and sustaining a culture of diversity, equity, and inclusion. Our commitment to these values is unwavering across all our work around the world.  We include and celebrate employees of diverse races, genders, religions, sexual orientations, ethnicities, nationalities, socioeconomic statuses, languages, (dis)abilities, ages, and religious commitments. These differences drive innovative solutions to meet the needs of our employees and clients. Culmen is an equal opportunity employer.