Position Summary
The Site Director, Clinical Operations is responsible for overall clinical site management, including site identification, feasibility, pre-study site evaluation, study start-up, site initiation, patient recruitment, monitoring, site close-out activities, inspection readiness and local regulatory and IRB/EC submissions of Codera's clinical studies at designated sites in accordance with study protocol(s), Standard Operating Procedures (SOPs), ICH-GCP guidelines and all applicable regulatory requirements. Using available systems and tools, the Site Director, Clinical Operations will monitor and oversee site activities both onsite and remotely to ensure that patients' rights, safety and well-being are protected and that the data generated at sites are complete and accurate. The Site Director, Clinical Operations will be accountable for patient enrollment and overall delivery of high-quality patient data in established timelines for all designated sites and/or assigned region.
Essential Duties and Responsibilities
- 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
Qualifications
- 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%
Relocation is not required; however, the successful candidate must be able to travel frequently (50-65%). Candidates based in Midwest region are preferred, but proximity to a major airport and flexibility for multi-day travel are essential.
The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice.
The estimated annual base salary for this position is $160,000 - $210,000, commensurate with experience and skills.
This role may be eligible for discretionary bonuses and other incentive programs.
Codera provides a comprehensive benefits package designed to support employees' physical, mental and financial health and include employer sponsored insurance plans including medical, dental and vision coverage; generous paid time off; retirement plan options and additional wellness and professional development programs
