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Clinical Research Associate – Site Director
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
