Clinical Research Nurse

The Clinical Research Coordinator RN – Start-Up supports and executes clinical trial start-up activities for the Client Center for Clinical Research (HCCR) at Client Memorial Presbyterian Hospital. This role coordinates FDA-regulated research, including industry-sponsored Phase I–IV trials, government-funded studies, and investigator-initiated research, ensuring timely and compliant study activation.

• Support clinical trial start-up activities to ensure study activation timelines are met.
• Manage study priorities and oversee tasks required for site activation.
• Determine study complexity and readiness prior to internal “go-letter” issuance.
• Coordinate required start-up activities, including:
• Clinical team system access (EDC, IXRS, web-based applications)
• Investigational Product (IP) receipt and supply coordination
• EPIC treatment build completion
• Site location determination and investigator identification

• Participate in feasibility assessments in collaboration with department leadership.
• Review clinical trial protocols to assess operational and financial feasibility.
• Evaluate staffing needs based on schedules of assessments and workload allocation.
• Identify requirements for special equipment, resources, or infrastructure.
• Provide clinical and operational insight into protocol feasibility and site readiness.

• Serve as an active member of the Start-Up Team.
• Collaborate with Start-Up Teams and Operational Managers to identify and mitigate barriers to study activation.
• Communicate project status, risks, and improvement opportunities to leadership in a timely manner.

• Support department-wide initiatives focused on research process improvement.
• Ensure adherence to FDA regulations, GCP guidelines, and institutional policies.
• Maintain proficiency with clinical research technologies, systems, and tools.

• Participate in required training, education programs, and weekly research meetings.
• Maintain flexibility to work extended or overtime hours as required to meet study deadlines.
• Travel to multiple sites and attend off-site meetings as needed.

• Minimum 5 years of clinical research experience
  , including 4+ years as a Clinical Research Coordinator or RN Coordinator
  .
• Extensive experience reviewing and assessing clinical trial protocols.
• Prior experience working with commercial IRBs
  .
• Strong knowledge of:
• FDA regulations and Good Clinical Practice (GCP)
• Clinical trial lifecycle and components
• Medical terminology
• Electronic medical records (EMR), CTMS, and related research systems
• Demonstrated leadership, organizational, and project management skills.
• Ability to manage conflict, adapt to change, and work effectively with diverse teams.
• Strong written and verbal communication skills across all mediums.
• Proven ability to build effective working relationships and foster collaboration.
• Demonstrated accountability, business acumen, and commitment to customer satisfaction.
• Ability to mentor, coach, and support team development while recognizing performance excellence.