Overview
The Assistant Regulatory Operations Manager (AROM) is a newly created position and will be responsible for aiding in oversight of the Leukemia disease group’s regulatory research portfolio. This position involves close collaboration with the Clinical Research Manager within the Leukemia disease center; assisting with the development and quality control of protocol documents prior to iRIS (protocol review management system) submission, assisting with New Protocol Application (NPA) vetting and prioritization, ensuring that iRIS submission, review and approval timelines / institutional benchmarks are met.
This position is the primary point person for the Leukemia regulatory team and will manage the delegation of quality assurance checks for iRIS submissions and assist with Regulatory-Coordinator onboarding, training, and daily supervision support. The AROM takes the lead as directed for the collaboration / navigation with the DFCI-IRB (institutional review board) contacts, clinical trial sponsors, DFCI-designated Principal Investigator (PI) and the disease-group Clinical Research Manager to facilitate and streamline each process within established timelines. The AROM is directly responsible for closely managing all regulatory submissions reaching the activation phase to ensure both Clinical and Regulatory Operation teams are on task, coordinating with Clinical Research Managers, Research Coordinators, and Clinical Research Coordinators as necessary.
The selected candidate may only work remotely within the New England states (ME, VT, NH, MA, CT, RI).
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.
Responsibilities
SUPERVISORY RESPONSIBILITIES: (no direct reports)
Qualifications
Minimum of 3 years of clinical research and regulatory coordination experience required.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
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.