Manager, Oncology Clinical Research Operations

hhccareers; Fairfield (CT); On-site; USD 120,000 - 170,000; Full time

Job summary

Hartford HealthCare in Connecticut is seeking a Manager, Oncology Clinical Research Operations to oversee a team of Clinical Research Coordinators and research nurses, ensuring efficient, compliant execution of oncology trials across a regional network.

The role emphasizes SOP development, budget oversight, start-up and enrollment support, regulatory documentation, and strong collaboration with sponsors and IRBs, with a focus on quality and timely study delivery.

Qualifications

• Bachelor's degree in a scientific or healthcare field.
• Minimum 5 years of clinical research experience, with at least 2 years in a leadership role.
• Oncology research experience is highly preferred.
• Certification as CCRP/CCRC/CCRA is highly desirable.

Responsibilities

• Oversee delivery of oncology trials including start-up, enrollment management, site engagement, monitoring planning, regulatory documentation, data quality and close-out.
• Develop and implement SOPs to optimize workflow and maintain quality control.
• Monitor study budgets, patient accrual rates, and data quality; ensure sponsor and IRB requirements are met.
• Directly supervise and mentor CRCs and research nurses, conduct performance reviews, and manage workload distribution.
• Ensure compliance with FDA guidelines, GCP, and institutional regulations; participate in audits and inspections.

Skills

Team Leadership

Clinical Research

Oncology Trials

Regulatory Compliance

Education

Bachelor's degree in a scientific or healthcare field

Job description

Every day, more than 40,000 Hartford HealthCare colleagues come to work with one thing in common: Pride in what we do, knowing every moment matters here. We invite you to become part of Connecticut’s most comprehensive healthcare network.

The Hartford HealthCare Cancer Institute focuses on offering our cancer patients an unparalleled network of coordinated services– all under one roof. Our system of care includes a truly integrated team with the most talented, experienced, and compassionate caregivers and physicians, backed by the latest cutting-edge technology.

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.

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

We take great care of careers.

With locations around the state, Hartford HealthCare offers exciting opportunities for career development and growth. Here, you are part of an organization on the cutting edge – helping to bring new technologies, breakthrough treatments and community education to countless men, women and children. We know that a thriving organization starts with thriving employees-- we provide a competitive benefits program designed to ensure work/life balance. Every moment matters. And this isyour moment.