This position works within the clinical research program and manage 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.
This manager will work within the Dana-Farber/Boston Childrenâ€™s Cancer and Blood Disorders Centerâ€™s Clinical and Translational Investigation Program (CTIP) to lead a team focused on banking and specimen-based research activities relevant to children with cancer and blood disorders.Â Â
Clinical Trials OperationsÂ
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.Â
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.Â
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.Â
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 Trials
The 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 & ComplianceÂ
Assumes responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance.Â
Assumes responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc. Implements systems to monitor portfolio compliance.Â
Responsible for the disease group's transition from paper to electronic regulatory binders. Will maintain per DFCI CTO standards.Â
Data Management & Clinical Trial MonitoringÂ
Assumes responsibilities for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for timely and complete data collection.Â
Regularly reports data compliance status to key stakeholders; i.e. DFCI PI, study Sponsor, DFCI CTO. Implements corrective action to maintain data compliance when necessary.
Submits required progress/tracking reports to key stakeholders, when applicable.Â
Staff Hiring, Supervision, Training & Development
Responsible for the recruitment and oversight of all of the research staff. Ensure that all staff complete required mandatory and ongoing training in a timely manner. Develops and oversees a program specific on-boarding and orientation process and conducts annual performance evaluations and competency assessments of research staff.
Develops a standard supervision schedule with research staff including periodic individual and group supervision meeting. Will develop and agenda, take attendance and document all applicable meetings.Â
Will communicate all personnel concerns to their immediate supervisor and to DFCI HR partner for the appropriate response and follow up.Â
Working with informatics team and research coordinators to create a dashboard of samples-based research across CTIP programs, including sample status, utilization, and annotation;
Managing the technical aspects of sample-based research including process improvements to increase sample quality, identifying and evaluating vendors utilized for assays, assessing and fulfilling needs of collaborators and investigators;
Partnering with other CTIP clinical research managers (CRMs) and coordinators (CRCs) involved with specimen-based research to review and develop protocol documents relevant to prospective specimen-based research and to monitor compliance with institutional policies and best practice for specimen-based research;
Streamlining workflows related to specimen acquisition and banking;
Hiring, training, and managing CRCs focused on specimen acquisition and banking;
Facilitate investigator access to samples and sample derivatives for approved research projects;
Develop relationships with programs throughout the Longwood Medical Area to support specimen-based research efforts within Pediatric Hematology-Oncology; and
Assist CRMs in establishing Materials Transfer Agreements (MTA) and Data Usage Agreements (DUAs) when applicable.
Bachelor's Degree required, with a minimum of 5 + years of related experience, or Master's Degree with 5 years related experience
Must 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.
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.
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.
Internal Number: 2021-23052
About Dana-Farber Cancer Institute
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 under-served members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.