The Clinical Research Manager works within the DFCI Multiple Myeloma clinical research program and manages the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Trials Office. The Clinical Research Manager, in collaboration with the program’s physicians and research nursing staff, are responsible for the design, implementation and evaluation of their program’s clinical research activities (therapeutic and non-therapeutic), all related regulatory and compliance oversight, and direct supervision of their program’s clinical research staff. The Clinical Research Manager is responsible for tracking and complying with clinical trial performance benchmarks; e.g. protocol and regulatory compliance, patient safety, staff development & training and financial goals, as defined by Senior Research Leadership and the DFCI Clinical Trials Office.
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
ResponsibilitiesClinical Trials Operations
Clinical Research Managers (CRM) are responsible for the oversight of their disease group's clinical trial portfolio and all related regulatory, compliance and performance metrics requirements. The CRM will oversee the processing of protocols through DFCI Institutional Review Board (and other institutions' IRBs) when appropriate. The CRM will collaborate with the DFCI Clinical Trials Office (CTO), the Office for Human Research Studies (OHRS) and the Quality Assurance for Clinical Trials (QACT) to fulfill local and federal requirements governing human clinical trials. The CRM will Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.The CRM will assist the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds.Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials.Work collaboratively with clinical research administration and grant managers to help monitor and reconcile all study and related grant finances as needed. Assists the principal investigator in preparing manuscripts for publication.The CRM will collaborate with the DFCI CTO and DF/HCC QACT to develop study forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center TrialsThe CRM will oversee the subject enrollment, protocol treatment and follow-up care processes for protocol patients.Oversees registration of protocol patients with QACT, study group registrar and pharmaceutical company as outlined in protocol.
Regulatory & Compliance
Data Management & Clinical Trial Monitoring
Staff Hiring, Supervision, Training & Development
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Bachelor's Degree required, with a minimum of 5 + years of related experience, or Master's Degree with 5 years related experienceMust be able to perform day to day responsibilities independently with little or no supervision from manager. Has very proficient knowledge of and ability to execute clinical trials start-up, active and close out phases. Has very proficient knowledge of clinical research local policy and federal regulation. Can easily identify complex regulatory scenarios, independently develops viable solutions to present to supervisor. Must be very proficient in the ability to manage personnel issues and to provide critical feedback to supervisees, when applicable.Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process. In addition has experience in protocol development, data compilation and analysis. The Manager will be skilled at developing tracking systems to ensure timely data management by the clinical research staff. They will also have expert knowledge of Federal and State regulations as they relate to research. Strong interpersonal, organizational and communication skills are required. Must have computer skills including the use of Microsoft Office and working knowledge of Livelink; EPIC and Oncore applications.
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.
EEOC Poster
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