Regulatory Operations Manager - Pediatrics

Overview

The Clinical and Translational Investigation Program (CTIP) was established in 2010 to centralize and standardize conduct of clinical research within the Dana-Farber/Boston Children’s Cancer and Blood Disorders Center. The mission of CTIP is to provide comprehensive infrastructure to collaborating investigators who conduct clinical and translational research relevant to children with cancer and blood disorders.

CTIP Regulatory unit will provide pan-CTIP support as part of our clinical research infrastructure. CTIP regulatory unit will support interventional studies to the IRB as well as assist with FDA submissions and IND management.

Reporting to the CTIP Associate Director for the Pediatric unit, the Regulatory Operations Manager (ROM) will oversee the CTIP Regulatory Unit, manage the development and quality control of protocol documents before IRIS submission, assisting with New Protocol Application (NPA) vetting and prioritization, ensuring that IRIS submission, review, and approval timelines / institutional benchmarks are met.

ROM will also help develop necessary processes and workflows, work collaboratively with other clinical research colleagues to share best practices and training, and provide professional development initiatives for regulatory coordinators.

The ROM (along with Regulatory coordinators) is responsible for closely managing regulatory submissions and communication process, following a quality control program that ensures study documents are of the highest quality to decrease or eliminate questions/conditions that hold up the approval and activation processes.

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:

• Meet regularly with the leadership / key stakeholders to identify, prepare, and ensure quality and regulatory compliance and completeness of all submissions into IRIS prior to submission

• Assist in the oversight of program’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 process

• Ensure oversight of the day-to-day coordination and overall management of sponsor activities for assigned clinical trials; industry sponsored, multi-center, PI-initiated trials, grant development and management, and secondary use protocols in collaboration with key stakeholders

• Meet regularly with program manager(s) to review and collaborate regarding regulatory workload prioritization. Work with leadership to identify priority trials and complete submissions through IRIS. Process protocols through DFCI Institutional Review Board (and other institutions' IRBs)

• Identify and manage operational, logistical, and regulatory challenges related to the start-up, active, and closeout phases of the clinical trial life cycle and act as a leader in overseeing their resolution. Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and assist the disease group’s Clinical Research Manager in their resolution

• Manage the regulatory documentation submissions that may include the preparation and submission of protocol application documents, informed consent documents, amendments, continuing reviews, events, and other submissions for SRC and IRB review and approval

• Support the disease team’s IND/IDE applications to the appropriate regulatory agencies including the Food and Drug Administration (FDA), Office of Biotechnology Activities (OBA)

• Support the maintenance of the essential document compliance for the disease group. Implementing systems to monitor and ensure regulatory document collection and maintain compliance and audit-ready state. Assist in audit preparations and represent the department during inspections when needed

• Create and maintain tracking for all subsequent submissions to the SRC / IRB; protocol & consent amendments, all required safety reporting, all required deviation, violation, exception, or other event reporting. Ensure various regulatory reporting requirements are met, Study Sponsor, FDA, IRB, etc.

• Serve as facilitator for study team and sponsor (as needed) regarding study status information, critical safety issues, upcoming protocol, consent and IDB amendments and applicable protocol training; responsible for the systematic documentation/tracking when applicable

• Provide training and will serve as a resource to other research and clinical personnel regarding clinical trials, protocols, GCP guidelines, federal regulations, and site SOPs

• Train new regulatory staff as applicable

• 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.

Qualifications:

• Bachelor’s degree in Biology, Life Sciences, or related field required

• 5 years of experience in clinical research and regulatory coordination required; 3 years of experience with a Master’s in related field

• Experience in protocol development

• Experience in an academic institution preferred

Knowledge, Skills, and Abilities:

• Very proficient knowledge of and ability to execute clinical trials start-up, active and close-out phases

• Very proficient knowledge of clinical research local policy and federal regulation

• 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 research

• Excellent organizational skills and attention to detail

• Excellent written and verbal communication and interpersonal skills

• Strong 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 applicable

• Ability to lead multiple projects simultaneously

• Ability to prepare, with minimal supervision, a summary of a clinical trial design, objectives and activities using established guidelines and governmental regulations in a clear, concise, and health-literate format

• Ability to easily identify complex regulatory scenarios and independently develop viable solutions to present to supervisor

Supervisory Responsibilities:

Supervises Regulatory Coordinators

Patient Contact:

No

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 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.

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Pay Transparency Statement

The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.

For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).

$92,400.00 - $105,500.00