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 Meets regularly with the Clinical Research Manager and/or key stakeholders to assist in identifying, preparing, and ensure quality and regulatory compliance and completeness of all submissions into IRIS prior to submission. Assists in the oversight of disease group's clinical trial portfolio and all related regulatory and compliance metrics requirements. Maintains knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial processAids the Clinical Research Manager regarding day-to-day coordination and overall management of sponsor activities for assigned clinical trials; industry sponsored, multi-center, and PI-initiated trials.Works with Clinical Research Manager to identify priority trials from disease center leadership and aid in the Regulatory Coordinators in activation tasks required for new projects and amendments.Relays and discusses operational, logistical, and regulatory challenges related to the start-up, active, and closeout phases of the clinical trial life cycle to Clinical Research Manager and disease-center leadership, assisting in overseeing their resolution.This position follows central and/or disease-team regulatory procedural checklists to ensure timely action and ownership over submission-level tasks are properly in line with IRIS submission milestones.Assists in the management and training of the regulatory documentation process regarding submissions that may include the preparation of protocol application documents, informed consent documents, amendments, continuing reviews, events, and other submissions for SRC (Scientific Research Committee) and IRB review and approval.Provides staff supervision and assistance in the maintenance of the essential document compliance for the disease group. In coordination with the ROM, implements systems to monitor and ensure regulatory document collection and to maintain compliance and audit-ready state. Assists in audit preparations and represent the department during inspections when needed.Assists PI with protocol development, consent form development, and initial application and collaborate with DF/HCC RIO and ODQ to develop study forms, database information, and to establish guidelines for monitoring data quality control for PI-initiated studies / multi-Center TrialsAssists ROM in oversight of all required safety reporting, all required deviation, violation, exception, or other event reporting.Trains new regulatory staff as applicable.Must be able to perform day to day responsibilities independently with minimal supervision from manager.Has the ability to identify regulatory scenarios that require consultation. Has a good understanding of clinical trials start-up, active and close out phases. Has a good understanding of clinical research local policy and federal regulation.SUPERVISORY RESPONSIBILITIES: (no direct reports)
Provides day-to-day supervision and support for regulatory coordinators and or for other staff as needed. This position is designed to be a transition role. It is intended for new managers with no prior supervisory experience. Qualifications Bachelor’s Degree required.Minimum of 3 years of clinical research and regulatory coordination experience required.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Must have the ability to think critically and with good professional judgment. Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment, and have attention to detail and follow-through skills.Demonstrated organization and time management/prioritization skills with the ability to work independently are required.Very proficient knowledge of and ability to execute clinical trials start-up, active and close out phases.Proficient knowledge of regulatory affairs, research ethics and the responsible conduct of researchStrong ability to work independently and with little direction, and balance multiple projects and tasks simultaneously.Strong ability to both work as a member of and effectively and proactively collaborate with multiple teams.Strong ability to identify and assist in managing personnel issues and to provide critical feedback to supervisees, when applicableAt 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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