Job Description:

• Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites
• Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
• Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies
• Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites
• Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines
• Develop and cultivate strong site relationships and ensure continuity of site relationships
• Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance
• Identify, assess, escalate and resolve site performance or quality issues in a timely manner
• Complete feasibility and site identification activities for new clinical studies
• Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments)
• Facilitate communication with appropriate site staff involved in start-up and IRB/EC submissions
• Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance
• Responsible for the development of site specific recruitment, retention and follow-up plans
• Facilitate and support investigator site audits and/or inspection activities as needed
• Perform remote data review and query resolution for designated sites
• Contribute to overall clinical operations team knowledge by sharing best practices and participating in improvement initiatives
• Coach and mentor colleagues as needed
• Contribute to the review of Codera’s systems and procedures as needed
• May be involved, when needed, in other areas of study management and staff training
• Execute other duties as assigned

Requirements:

• Bachelor’s Degree in a Life Science discipline required
• Bachelor’s Degree in Nursing or RN a plus
• Minimum 3 years of direct site monitoring experience required
• Detailed understanding of all aspects of clinical site monitoring as well as understanding of overall drug development required
• Thorough understanding of FDA, ICH and GCP guidelines and applicable local regulations
• Excellent critical thinking skills and ability to understand complex patient histories, medical terminology and treatment landscapes
• Ability to interpret study level metrics data and proactively identify and mitigate risks through study lifecycle
• Detail-oriented, organized and committed to quality and consistency
• Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines
• Excellent team-interaction skills and ability to work successfully in team settings
• Ability to work in a dynamic environment with a high degree of flexibility
• Ability to contribute to the culture of process improvement with a focus on streamlining processes adding value to the company business and needs
• Excellent written and verbal communication skills
• Experience and proven proficiency in CTMS and eTMF systems preferred
• Must be willing and able to travel up to 50-65%

Benefits:

• employer sponsored insurance plans including medical, dental and vision coverage
• generous paid time off
• retirement plan options
• additional wellness and professional development programs