Job description

Job ID:
33274

Location:
10 Brookline Place West, Brookline, MA 02445

Category:
Clinical Research

Employment Type:
Full time

Work Location:
Full Remote: Occasional time on campus

Overview

The Senior Regulatory Operations Manager (Senior ROM) reports directly to the CTO Associate Director – Regulatory Operations, the CTO Sr. Director and assigned disease group research leadership. This position is responsible for overseeing the specific assigned disease group’s research portfolio and, when applicable, to share regulatory oversight within the assigned regulatory POD. Will be responsible for managing the development and quality control of protocol documents preparation prior to IRIS 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 responsible for the collaboration / navigation with the DFCI IRB contacts, clinical trial sponsors, DFCI designated Principal Investigator(s) and the disease group Clinical Research Manager(s) to facilitate and streamline each process within established timelines. The Senior ROM is responsible for closely managing regulatory submissions and communication 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.

This position mitigates inconsistencies within study documents, keeps protocols and amendments on track, and ensures appropriate quality control strategy at each step throughout the protocol life cycle. The Senior ROM also works collaboratively with other ROM colleagues to share best practices, workload metric and training / professional development initiatives for regulatory coordinators.

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

PRIMARY DUTIES AND RESPONSIBILITIES:
Oversee and supervise all aspects of assigned POD & specific program’s prioritization of submissions with placing a strong emphasis on Phase I trials in collaboration with key stakeholders
Oversee and ensure regulatory staff comply with all sponsor activities that include coordinating trial startup and site startup activities, letter of intent development and budget analysis, providing training to regulatory staff, regulatory submissions and coordinating communication with regulatory authorities and other key stakeholders
Oversee and report on the assigned deliverables, to identify variances in expected outcomes and to develop contingency plans when necessary to keep protocol and other submission milestones on track
Oversee the execution of clinical trials start-up, active and close out phases. Maintain and acquire knowledge of clinical research local policy and federal regulations. Identify complex regulatory scenarios, develop viable solutions to improve processes in collaboration with key stakeholders
Meet regularly with the CTO leadership / key stakeholders to identify, prepare, and ensure quality and regulatory compliance and completeness of all submissions into IRIS prior to submission
Assist the principal investigator(s) 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
Assist in the oversight of assigned POD & specific assigned disease group's clinical trial portfolio and all related regulatory and compliance metrics requirements.
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 CTO leadership / disease center leader, Clinical Research Manager(s) to review and collaborate regarding regulatory workload prioritization. Work with all stakeholders 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
Manage the IND/IDE applications to the appropriate regulatory agencies including the Food and Drug Administration (FDA), Office of Biotechnology Activities (OBA)
Manage 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
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 Trials
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 required are met, Study Sponsor, FDA, IRB etc.
Serve as facilitator for study team and sponsor 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
Will be asked to provide in-service 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
May be asked to provide in-service training and 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

SUPERVISORY RESPONSIBILITIES:
Supervises Regulatory Coordinators and Consent Writers. May also supervise other specialized regulatory staff.

Qualifications

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.

MINIMUM JOB QUALIFICATIONS:
Bachelor’s degree in Biology, Life Sciences, or related field required
7 years of experience in clinical research and regulatory coordination required; 5 years of experience with a Master’s in related field
Experience in protocol development
Experience in an academic institution preferred

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Expert knowledge of and ability to execute clinical trials start-up, active and close out phases
Expert knowledge of clinical research local policy and federal regulation
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 independently navigate complex personnel issues in collaboration with key stakeholders
Strong ability to both work as a member of and effectively and proactively collaborate with multiple teams
Ability to navigate and interpret complex regulatory strategy and operationalize when applicable with little or no supervision
Ability to operate proactively and to maintain compliance and best practice
Ability to problem solve and work collaboratively with key stakeholders
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

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.

EEOC Poster

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