Oversight Monitor - Serbia

KPS Life is seeking an experienced freelance part-time Oversight Monitor based in Serbia.
Primary Purpose And Function
The primary responsibility of the Oversight Monitor (OM) is to ensure adequate Sponsor oversight of the study conduct and study monitoring within the assigned country or region.
The OM
Major Duties and Responsibilities:

• Addresses issues identified with study conduct, monitoring and site management with Sponsor’s management, are appropriately communicated/escalated and follows up through resolution.
• Reviews the submission documents for IRBs/IECs and Health Authorities as appropriate for assigned sites/countries/region.
• Ensures high quality conduct and execution of clinical studies at sites according to the protocol and study team and governance requirements in compliance with quality, regional and regulatory (GCP) standards.
• Maintains good communication and working relationships with investigators/site staff and assigned monitors.
• Will conduct oversight monitoring visits, co-monitoring visits, monitoring visit report reviews and other Sponsor oversight activities per applicable study plans.
• Contributes to development and execution of the Oversight Monitoring plan.
• Ensures inspection readiness at the study sites and follow up corrective/preventive actions.
• May assist with translations or verification of translations.

Competencies
The OM will have:

• Comprehensive/extensive knowledge of ICH guidelines/GCP and remains current on medical/scientific aspects.
• Demonstrated innovation skills, drive, energy and enthusiasm to deliver the study program objectives.
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies.
• Computer literacy in appropriate software(s).
• Excellent planning, time management and coordination skills.
• The ability to identify, solve and escalate issues that arise at study sites and within site management
• Excellent interpersonal (written and verbal) and decision-making skills.
• Demonstrated management of monitoring and site management tasks.

The OM Will Have

• A minimum of 8+ years’ relevant clinical research (or related) experience.
• Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
• Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
• 6+ years’ experience in monitoring and site management of industry sponsored clinical research (CRA, Clinical Trial Monitor, or equivalent).
• The ability to participate in preparation, conduct and follow up of audits and site inspections.
• A degree (BSc or equivalent preferred) in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area.
• A thorough understanding of the drug development and clinical trial process.

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