Clinical Research Manager - GI Oncology

The Clinical Research Manager (CRM) will work within the GI Oncology 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 CRM, in collaboration with the program’s physicians and research nursing staff, is 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 CRM 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 (CTO). CLINICAL TRIAL 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 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 & COMPLIANCE Assumes responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance. Assumes responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations, etc. Implements systems to monitor portfolio compliance. Responsible for the disease group's transition from paper to electronic regulatory binders. Will maintain per DFCI CTO standards. DATA MANAGEMENT & CLINICAL TRIAL MONITORING Assumes responsibilities 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. Implements corrective action to maintain data compliance when necessary. Submits required progress/tracking reports to key stakeholders, when applicable. 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 onboarding 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 meetings. Will develop an agenda, take attendance, and document all applicable meetings. Will communicate all personnel concerns to their immediate supervisor and to DFCI HR partner for the appropriate response and follow-up. MINIMUM REQUIREMENTS: Bachelor's Degree required. Minimum of 5+ years of related experience, or Master's Degree with 5 years related experience. KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED: Must be able to perform day-to-day responsibilities independently with little or no supervision from manager. Must have very proficient knowledge of and ability to execute clinical trials start-up, active, and close-out phases. Must have very proficient knowledge of clinical research local policy and federal regulation. Must efficiently identify complex regulatory scenarios, independently develop 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. Must have knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process. Experience in protocol development, data compilation, and analysis. Skilled at developing tracking systems to ensure timely data management by the clinical research staff. 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. 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. 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.

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