Dana-Farber Cancer Institute
Assistant Clinical Research Manager - Head & Neck Oncology
Dana-Farber Cancer Institute, Boston, Massachusetts, us, 02298
Overview
Assistant Clinical Research Manager - Head & Neck Oncology is a role within the Head & Neck Oncology clinical research program. The position will assist in the management of the research team in the overall conduct of clinical trials under Good Clinical Practice, under the auspices of the Principal Investigator. The role involves collaboration with the program’s Clinical Research Managers, physicians, and research nursing staff to design, implement, and evaluate clinical research activities, regulatory oversight, and day-to-day supervision of program staff as needed. This is a transition role intended for new managers with no prior supervisory experience. Responsibilities
Assist the Clinical Research Manager with oversight of the disease group’s clinical trial portfolio and related regulatory and compliance requirements. Assist with all aspects of study start-up, active management, and close-out activities for the group’s portfolio. Track 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 the oversight of registration of protocol patients, study group registrar, and pharmaceutical company as outlined in the protocol. Regulatory & Compliance
Assist in essential document compliance for the portfolio. Implement systems to monitor and ensure regulatory document collection and maintenance compliance. Assist with clinical trial reporting requirements, including safety events, annual approvals, and deviations. May implement systems to monitor portfolio compliance and help maintain an audit-ready research environment. Data Management & Monitoring
Assist with data management and compliance for the portfolio. Maintain schedules and procedures for timely and complete data collection. Regularly report data compliance status to key stakeholders (e.g., DFCI PI, study Sponsor, DFCI CTO). Help implement corrective actions to maintain data compliance when necessary. Submit required progress/tracking reports to key stakeholders when applicable. Staff Training & Development
Assist in recruitment and oversight of coordinator staff and ensure mandatory training is completed timely. Help implement program-specific onboarding and orientation; participate in annual performance evaluations and competency assessments as needed. Bachelor’s Degree required, with a minimum of 3+ years of related experience preferred. Ability to function independently, think critically, and exercise good professional judgment. Competencies
Ability to perform day-to-day responsibilities independently with minimal supervision. Ability to identify regulatory scenarios that require consultation. Understanding of clinical trials start-up, active, and close-out phases. Understanding of local policy and federal regulation in clinical research. Knowledge, Skills, and Abilities
Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process. Experience in protocol development, data compilation, and analysis. Understanding of tracking systems used to ensure timely data management by the clinical research staff. Understanding of Federal and State regulations related to research. Strong interpersonal, organizational, and communication skills. Computer skills including Microsoft Office. Equal Opportunity
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. Other
Location: Boston area (Dana-Farber Cancer Institute). Salary range and posting cadence are shown where applicable. This description includes the essential functions and qualifications for the role. Referrals may increase interview chances.
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Assistant Clinical Research Manager - Head & Neck Oncology is a role within the Head & Neck Oncology clinical research program. The position will assist in the management of the research team in the overall conduct of clinical trials under Good Clinical Practice, under the auspices of the Principal Investigator. The role involves collaboration with the program’s Clinical Research Managers, physicians, and research nursing staff to design, implement, and evaluate clinical research activities, regulatory oversight, and day-to-day supervision of program staff as needed. This is a transition role intended for new managers with no prior supervisory experience. Responsibilities
Assist the Clinical Research Manager with oversight of the disease group’s clinical trial portfolio and related regulatory and compliance requirements. Assist with all aspects of study start-up, active management, and close-out activities for the group’s portfolio. Track 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 the oversight of registration of protocol patients, study group registrar, and pharmaceutical company as outlined in the protocol. Regulatory & Compliance
Assist in essential document compliance for the portfolio. Implement systems to monitor and ensure regulatory document collection and maintenance compliance. Assist with clinical trial reporting requirements, including safety events, annual approvals, and deviations. May implement systems to monitor portfolio compliance and help maintain an audit-ready research environment. Data Management & Monitoring
Assist with data management and compliance for the portfolio. Maintain schedules and procedures for timely and complete data collection. Regularly report data compliance status to key stakeholders (e.g., DFCI PI, study Sponsor, DFCI CTO). Help implement corrective actions to maintain data compliance when necessary. Submit required progress/tracking reports to key stakeholders when applicable. Staff Training & Development
Assist in recruitment and oversight of coordinator staff and ensure mandatory training is completed timely. Help implement program-specific onboarding and orientation; participate in annual performance evaluations and competency assessments as needed. Bachelor’s Degree required, with a minimum of 3+ years of related experience preferred. Ability to function independently, think critically, and exercise good professional judgment. Competencies
Ability to perform day-to-day responsibilities independently with minimal supervision. Ability to identify regulatory scenarios that require consultation. Understanding of clinical trials start-up, active, and close-out phases. Understanding of local policy and federal regulation in clinical research. Knowledge, Skills, and Abilities
Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process. Experience in protocol development, data compilation, and analysis. Understanding of tracking systems used to ensure timely data management by the clinical research staff. Understanding of Federal and State regulations related to research. Strong interpersonal, organizational, and communication skills. Computer skills including Microsoft Office. Equal Opportunity
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. Other
Location: Boston area (Dana-Farber Cancer Institute). Salary range and posting cadence are shown where applicable. This description includes the essential functions and qualifications for the role. Referrals may increase interview chances.
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