Senior Clinical Research Manager - Pediatric Experimental Therapeutics and Cancer Cellular Therapy
Dana-Farber Cancer Institute
Location: Boston, Massachusetts
Internal Number: 2021-25589
The Clinical Research Managers work 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 Principal Investigators 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 position will manage the Pediatric Experimental Therapeutics program and the Pediatric Cancer Cellular Therapy program.
This position is 2-3 days remote. Only applicants living in Massachusetts, Rhode Island, or New Hampshire at the time of employment will be considered.
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.??This position will manage the existing Pediatric Experimental Therapeutics program and a new Pediatric Cancer Cellular Therapy program.??
Clinical 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.??
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 non-nursing research staff in Pediatric Experimental Therapeutics and Pediatric Cellular Immunotherapy programs. 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 non-nursing research staff.
Develops a standard supervision schedule with research staff including periodic individual and group supervision meeting.
Will communicate all personnel concerns to their immediate supervisor and to DFCI HR partner for the appropriate response and follow up.
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 7+ years of related experience or Master Degree with 5+ years 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.
Has expert knowledge of and is fully proficient in ability to execute clinical trials start-up, active and close out phases. Is fully proficient in their knowledge of clinical research local policy and federal regulation. Strong ability to independently navigate complex personnel issues in collaboration with key stakeholders. Can navigate and or interpret complex regulatory strategy and can operationalize when applicable with little or no supervision. Operates proactively to maintain compliance and best practice. Able to problem solve and work collaboratively with key stakeholders. May be asked to provide in-service training and can to serve as a resource to other clinical personnel including physicians, nurses, pharmacists and other allied health professionals regarding clinical trials, protocols, GCP guidelines, federal regulations and site SOPs.
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.
Prior experience in pediatric clinical research preferred, but not required.
Prior experience with phase 1 clinical trials and/or cellular therapy trials preferred, but not required.
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.
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.