Assistant Clinical Research Manager - Breast Oncology Clinical Trials

Assistant Clinical Research Manager (ACRM) position within the Breast Oncology clinical research program. Responsible for assisting the Clinical Research Manager in managing the research team and conducting clinical trials in compliance with Good Clinical Practice and under the auspices of the Principal Investigator. Location: Boston, Massachusetts – Dana‑Farber Cancer Institute. Clinical Trials Operations Assist the Clinical Research Manager with oversight of the disease group’s clinical trial portfolio and all related regulatory and compliance requirements. Assist with study start‑up, active, and close‑out activities, tracking protocol development, submission, review, and approval milestones. Assist with oversight of subject enrollment, protocol treatment, and follow‑up care processes for protocol patients. Assist with registration of protocol patients, coordination with the study group registrar and pharmaceutical companies as outlined in the protocol. Regulatory & Compliance Assist with essential document compliance for the entire portfolio and implement systems to monitor and ensure regulatory document collection and maintenance compliance. Assist with all clinical trial reporting requirements, including safety events, annual approvals, and deviations, and may implement systems to monitor portfolio compliance. Help maintain an “audit‑ready” research environment with the study team. Data Management & Clinical Trial Monitoring Assist the Clinical Research Manager with data management and compliance for the entire portfolio, maintaining schedules and procedures for timely and complete data collection. Regularly report data compliance status to key stakeholders such as the DFCI Principal Investigator, study sponsor, and DFCI CTO, and help implement corrective actions when necessary. Submit required progress and tracking reports to key stakeholders when applicable. Staff Training & Development Assist the Clinical Research Manager with recruitment and oversight of coordinator staff and ensure staff complete mandatory training in a timely manner. Help implement program‑specific onboarding and orientation processes and may participate in annual performance evaluations and competency assessments of research staff as needed. Knowledge, Skills, and Abilities Perform day‑to‑day responsibilities independently with minimal supervision. Identify regulatory scenarios that require consultation. Understand clinical trials start‑up, active, and close‑out phases. Understand clinical research, local policy, and federal regulation. Knowledge of cancer biology, treatment modalities, and the clinical trial process. Experience in protocol development, data compilation, and analysis. Understand tracking systems used for timely data management by clinical research staff. Understand Federal and State regulations related to research and possess strong interpersonal, organizational, and communication skills. Computer skills, including Microsoft Office. Minimum Job Qualifications Bachelor’s Degree required. Minimum of 3 plus years of related experience preferred. Ability to function independently, think critically, and exercise good professional judgment. License/Certification/Registration N/A Supervisory Responsibilities Provide day‑to‑day supervision for study management staff, including clinical research coordinators, students, volunteers, and other research assistants as needed. Patient Contact May have contact with patients of all ages and populations. Pay Range $70,000.00 - $85,300.00 EEO Statement Dana‑Farber Cancer Institute is an equal‑opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law. #J-18808-Ljbffr