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Manager, Oncology Clinical Research Operations

Hartford HealthCare

Fairfield, CTJobSeen 1mo agoSeen in employer's feed 4 days ago

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At a glance

Compensation
No compensation found
Location
Fairfield, CT
Work Authorization
Not specified

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Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

Hartford HealthCare is hiring a Manager, Oncology Clinical Research Operations. The Manager, Oncology Clinical Research Operations leads a team of Clinical Research Coordinators and research nurses to ensure efficient, compliant execution of oncology clinical trials at Hartford HealthCare’s Cancer Institute in Fairfield, CT. Responsibilities include overseeing trial start‑up, enrollment, budgeting, regulatory documentation, data quality, and staff supervision while maintaining adherence to FDA, GCP, and sponsor requirements.

Key focus areas include Guide delivery of trials including start‑up, enrollment management, site engagement, monitoring planning and execution, regulatory documentation, data cleaning, and close‑out., Develop and implement SOPs to optimize workflow and maintain quality control., and Initiate improvements to enhance efficiency and quality of work on assigned trials..

Important skills include Clinical Research Operations, Oncology Clinical Research, Trial Start-up, Enrollment Management, Site Engagement, and Monitoring Planning.

Skills & qualifications

RequiredNice to have

Skills

Clinical Research OperationsOncology Clinical ResearchTrial Start-UpEnrollment ManagementSite EngagementMonitoring PlanningMonitoring ExecutionRegulatory DocumentationData CleaningClose-OutSOP DevelopmentBudget MonitoringPatient AccrualData QualityStakeholder ManagementData CompilationReportingRegulatory ComplianceFDA GuidelinesGood Clinical PracticeAudit PreparationAudit ParticipationAudit Findings ResponseLeadershipSupervisionPerformance ReviewResource Allocation

Qualifications

Bachelor's Degree in Scientific Field5+ Years Clinical Research2+ Years Leadership ExperienceOncology Research ExperienceClinical Research Professional Certification

Full 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 is your moment. Job: *Research Organization: *Hartford HealthCare Corp. Title: Manager, Oncology Clinical Research Operations Location: Connecticut-Fairfield-4185 Black Rock Turnpike (10596) Requisition ID: 26161173

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