Clinical Research Manager - Pediatric Oncology Solid Tumor
Dana-Farber Cancer Institute
Location: Brookline, Massachusetts
Internal Number: 2021-24471
The pediatric Solid Tumor Program at Dana-Farber Cancer Institute is seeking to hire a Clinical Research Manager to oversee the clinical trials team and research portfolio. The pediatric Solid Tumor Program is one of the largest in the world and treats children with a range of solid tumor diagnoses providing novel and cutting-edge therapies for these rare diseases. The Clinical Research Manager oversee the clinical trials research team, working closely with an Assistant Clinical Research Manager and a team of clinical research coordinators on 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 will have the opportunity to engage with pediatric oncologists, researchers, and research nursing staff, to design, implement and oversee regulatory and compliance work related to the program???s clinical research activities. The Manager will also work to track and comply with clinical trial performance benchmarks (patient safety, staff development and training, and financial goals) as defined by Senior Research Leadership and the DFCI Clinical Trials Office. It is anticipated that this job opportunity will to lead to educational opportunities as well as the prospect for advancement within the division and the Institute.
The position is a unique and rare leadership opportunity within the Clinical Translational Research Program (CTIP).
This position is 2-3 days remote. Only applicants that resides in Massachusetts, Rhode Island, or New Hampshire at the time of employment will be considered. Candidates must have the ability to work from our Boston, MA office for onsite days.??
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.
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.??
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 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.??
Bachelor's Degree required, with a minimum of 5 years of related experience preferred.
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.
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.