Oncology Clinical Research Operations Lead

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

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.