Clinical Research Manager - Breast Oncology

About the role

The Clinical Research Manager (CRM) position works within the Breast Oncology clinical research program. They manage the research team in conducting clinical trials under Good Clinical Practice, ensuring compliance with regulatory and compliance requirements. They also oversee the clinical research staff and are responsible for tracking and complying with clinical trial performance benchmarks.

Responsibilities

• Manage the design, implementation, and evaluation of clinical research activities, including therapeutic and non-therapeutic studies.
• Collaborate with physicians, research nursing staff, and the Clinical Trials Office to ensure regulatory and compliance oversight.
• Oversee the processing of protocols through Institutional Review Boards (IRBs).
• Identify and manage operational, logistical, and regulatory challenges related to clinical trials.
• Assist the principal investigator in developing the protocol budget and managing study finances.
• Oversee the subject enrollment, protocol treatment, and follow-up care processes for protocol patients.
• Ensure data entry and review accuracy in the Clinical Trial Management System.
• Absorb responsibility for essential document compliance and ensure regulatory document collection and maintenance compliance.
• Maintain schedules and procedures for timely and complete data collection, and report data compliance status to key stakeholders.
• Recruit, oversee, and train research staff, and conduct performance evaluations and competency assessments.
• Develop and oversee a program-specific on-boarding and orientation process.

Requirements

• Bachelor’s Degree required, with a minimum of 5 years of related experience preferred.
• Proficient in cancer as a disease process, cancer treatment modalities, and the clinical trial process.
• Experience in protocol development, data compilation and analysis.
• Expert knowledge of Federal and State regulations as they relate to research.
• Strong interpersonal, organizational, and communication skills.
• Computer skills including the use of Microsoft Office and working knowledge of Livelink, EPIC, and OnCore applications.

Qualifications

• Must be able to perform day-to-day responsibilities independently with minimal supervision.
• Must have previous supervisory experience.
• Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
• Experience in protocol development, data compilation and analysis.
• Skilled at developing tracking systems to ensure timely data management by the clinical research staff.
• Expert knowledge of Federal and State regulations as they relate to research.
• Strong interpersonal, organizational, and communication skills.
• Computer skills including the use of Microsoft Office and working knowledge of Livelink, EPIC, and OnCore applications.

Skills

• Ability to identify complex regulatory scenarios that require consultation.
• Experience in protocol development, data compilation and analysis.
• Skilled at developing tracking systems to ensure timely data management by the clinical research staff.
• Expert knowledge of Federal and State regulations as they relate to research.
• Strong interpersonal, organizational, and communication skills.
• Computer skills including the use of Microsoft Office and working knowledge of Livelink, EPIC, and OnCore applications.

Benefits

Dana-Farber Cancer Institute offers a supportive and inclusive environment where every patient, family, and staff member feels they belong. The institute is committed to having a diverse workforce and encourages applications from candidates who offer multifaceted experiences.

Pay

$77,400.00 - $102,800.00