Dana-Farber Cancer Institute Assistant Clinical Research Manager - Pediatric Oncology, Solid Tumor Program in Boston, Massachusetts
The Assistant Clinical Research Manager will work within the Solid Tumor Program in Pediatric Oncology. The ACRM will join a team of clinical research coordinators and project managers to support the full research portfolio of the Department’s Investigators. The Solid Tumor program maintains a portfolio of over 100 active studies that include early and late phase PI-Initiated trials (local and multicenter), cooperative group clinical trials, specimen banking protocols and research protocols with a genetic and genomic focus. The ARCM will assist in the management of the research team in the overall conduct of clinical trials and other research projects using Good Clinical Practice under the auspices of the Principal Investigator. These positions, in collaboration with the program’s Clinical research Managers physicians and research nursing staff, are responsible for assisting with the design, implementation and evaluation of their program’s clinical research activities, related regulatory oversight, and will provide day to day supervision of their program’s clinical research staff as needed.
This position is designed to be a transition role. It is intended for new managers with no prior supervisory experience.
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
Clinical Trials Operations
Assistant Clinical Research Manager (ACRM) will be responsible for assisting the Clinical Research Manager with the oversight of their disease group’s clinical trial and research project portfolio and all related regulatory and compliance requirements.
The ACRM will assist the CRM will all aspects of study start up, active and close out activities for the group’s portfolio. They will be responsible for the required tracking of all protocol development, submission, review and approval milestones.
The ACRM will assist with the 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 protocol.
Regulatory & Compliance
Assists in the responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance.
Assists in the responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc. May implement systems to monitor portfolio compliance.
Assists the study team to be maintain an “audit ready” research environment
Data Management & Clinical Trial Monitoring
Assists CRM with responsibility for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for timely and complete data collection.
Regularly reports data compliance status to key stakeholders; i.e. DFCI PI, study Sponsor, DFCI CTO. Helps to implement corrective action to maintain data compliance when necessary.
Submits required “progress / tracking “reports to key stakeholders, when applicable.
Staff Training & Development
Will assist the CRM with the recruitment and oversight of coordinator staff as well as ensures that staff have completed mandatory training in a timely manner. Will help implement program specific on-boarding and orientation process and may participate in annual performance evaluations and competency assessments of research staff as needed.
Bachelor's Degree required.
Clinical research experience required; minimum of 3-5 years of related experience preferred.
Experience in protocol development, data compilation and analysis.
Must be able to perform day to day responsibilities independently with minimal supervision from manager.
Has the ability to identify regulatory scenarios that require consultation. Has a good understanding of clinical trials start-up, active and close out phases.
Has a good understanding of clinical research local policy and federal regulation.
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 groups as protected by law.
Job ID: 2020-17609
External Company URL: www.dana-farber.org
Street: 450 Brookline Ave