Clinical Research Associate – Site Director

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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
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