Manager, Oncology Clinical Research Operations

Hartford Healthcare•Fairfield, CT

About The Position

The 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. This role involves operational oversight of trial delivery, including start-up, enrollment management, site engagement, monitoring, regulatory documentation, data cleaning, and close-out. The manager will develop and implement standard operating procedures (SOPs) to optimize workflow and maintain quality control, initiate improvements to enhance efficiency and quality, and monitor study budgets, patient accrual rates, and data quality. They will also serve as a point of contact for sponsors, IRBs, and internal stakeholders, and compile data on trial activities to ensure quality of data and reporting. Additionally, the role includes team leadership and supervision, where the manager will directly supervise and mentor CRCs and research nurses, foster a collaborative environment, conduct performance reviews, provide feedback, assist in professional development, and oversee workload distribution and resource allocation. Compliance and quality assurance are critical, ensuring all research activities meet federal, state, and institutional regulations, including FDA guidelines and Good Clinical Practice (GCP), as well as sponsor requirements. The manager will also prepare for and participate in audits, monitoring visits, and inspections, and respond to any findings.

Requirements

Bachelor's degree in a scientific or healthcare-related field required
Minimum of 5 years of experience in clinical research
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

Responsibilities

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.
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.
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.