Clinical Research Manager

Clinical Pediatric Clinical Research Manager IIThe Clinical Pediatric Clinical Research Manager II provides leadership for pediatric clinical research operations and oversees the research team in the execution of clinical trials in accordance with Good Clinical Practice (GCP), under the direction of the Principal Investigator and the Clinical Trials Office. This role is responsible for managing the day-to-day conduct of therapeutic and non-therapeutic studies while ensuring high standards for quality, compliance, and patient safety. Working closely with physicians, research nursing staff, and other program partners, this position supports the planning, implementation, and evaluation of clinical research activities across the program. The manager directs regulatory and compliance efforts, supervises clinical research personnel, and helps ensure studies are conducted efficiently and in alignment with institutional, sponsor, and regulatory requirements. The Clinical Research Manager II is also accountable for monitoring and achieving key performance expectations, including protocol adherence, regulatory compliance, patient safety outcomes, staff training and development, and financial targets established by senior research leadership and the 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.Primary Duties And ResponsibilitiesClinical Trials OperationsClinical 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 Office of Data Quality (ODQ) 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.In collaboration with clinical research administration and grant managers, may maintain, monitor and reconcile all study and related grant finances. These may include budget development, expenditure tracking, procurement, salary offset worksheets and staffing.Assists the principal investigator in preparing manuscripts for publication.The CRM will collaborate with the DFCI CTO, and DF/HCC ODQ 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 ODQ or OnCore policies and pharmaceutical company as outlined in protocol.If applicable for coverage or trial assignments, responsible for data entry of study-specific activity, including but not limited to subject visit tracking, monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed.Responsible for reviewing, approving, and reporting on data entry completed by supervised research staff in Clinical Trial Management System. The data entry oversight may include, but is not limited to, Subject Visit Tracking for subject-specific visits, time and effort spent on study-specific activities and other administrative tasks, etc.Regulatory & ComplianceAssumes 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 MonitoringAssumes 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 & DevelopmentResponsible 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.Will communicate all personnel concerns to their immediate supervisor and to DFCI HR partner for the appropriate response and follow up.CompetenciesMust 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, Technical Skills, And Abilities RequiredKnowledge 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.Minimum Job QualificationsBachelor's Degree required, with a minimum of 5 + years of related experience, or Master's Degree with 5 years related experienceSupervisory ResponsibilitiesSupervises study management staff, including clinical research coordinators, students, volunteers, and other research assistants. Number of Direct Reports 6-10Patient Contact:May have contact with pediatric patients and families/guardians of patientAt 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 committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate 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.