Manager, Oncology Clinical Research Operations is responsible for managing a team of Clinical Research Coordinators (CRCs) and research nurses ensuring the efficient and compliant execution of all oncology clinical trials within a region of Hartford HealthCare
Operational Oversight: - Guide the delivery of a trial, including support for start-up, enrollment management, site engagement, monitoring planning and execution, regulatory documentation, data cleaning activities, and close-out.
- Develop and implement standard operating procedures (SOPs) to optimize workflow and maintain quality control.
- Initiate improvements to enhance the efficiency and the quality of the work performed on assigned trials.
- Monitor study budgets, patient accrual rates, and data quality.
- Act as a point of contact for sponsors, institutional review boards (IRB), and internal stakeholders.
- Compile data on trial activities and ensure quality of data and reporting.
Team Leadership and Supervision: - Directly supervise and mentor a team of Clinical Research Coordinators and Research Nurses, fostering a collaborative and high-performing environment.
- Conduct performance reviews, provide ongoing feedback, and assist in professional development for the team.
- Oversee workload distribution and resource allocation to ensure all studies are adequately staffed and executed on time.
Compliance and Quality Assurance: - Ensure all research activities meet federal, state, and institutional regulations, including FDA guidelines and Good Clinical Practice (GCP).
- Ensure all research activities comply sponsor requirements.
- Prepare for and participate in internal and external audits, monitoring visits and inspections.
- Review and respond to any monitoring and auditing findings as requested.
Qualifications: Education: - Bachelor's degree in a scientific or healthcare-related field required
Experience:
- Minimum of 5 years of experience in clinical research, with at least 2 years in a leadership or supervisory role.
- Proven experience in oncology research is highly preferred.
- Certification as a Clinical Research Professional (e.g., CCRP, CCRC, CCRA) is highly desirable
