The Clinical Research Manager (CRM) will work within the Cohort Studies Program in the Department of Breast Oncology. This position will assist in the management of the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. The CRM will be responsible for assigned day-to-day coordination and overall management of activities in cohort studies. Responsibilities include coordinating cohort studies activities and related studies, assisting with the design, implementation, and evaluation of their program’s research activities, providing training to research staff, regulatory submissions, and participant accrual tracking and reporting. The CRM will be responsible to report on his or her defined deliverables, to identify variances in project plan and to develop contingency plans when necessary to keep project milestones on track. Specific tasks and responsibilities are varied and dependent upon project aims, scope and duration.

The Clinical Research Manager may also be assigned to oversee various operational and training aspects of the EPIC / OnCore application used by the DFCI Research Enterprise. The CRM will work closely and collaboratively with a variety of faculty and staff at all levels throughout DFCI/BWH, and also will work in collaboration with many other key stakeholders. The CRM will develop infrastructure, procedures, and tracking systems for project management services performed. Project management responsibilities would include coordinating the on-boarding of new research staff training, maintaining workflows, facilitating all questions related to study procedures and defining grant and research specific reporting for the DFCI. The CRM will be supervised and supported by the Associate Director of Cohort Studies to develop and implement strategies that will ensure compliance, consistency, and accountability in all assigned clinical research activities conducted within the system at DFCI. This individual is responsible for creating a proactive, knowledgeable, and cohesive project management platform that will support the research community.

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.

The Clinical Research Manager will work independently under general supervision of a senior manager within their disease group or Clinical Trials Office. This position may be responsible for some or all of the following:

STUDY OPERATIONS:

• Responsible for day-to-day oversight and management of assigned projects related to the Cohort Studies program.
• Initiates, plans, facilitates and oversees the research project start-up, active and close out phases; for studies and activities within the Cohort Studies program.
• Responsible for scheduling research team meetings and conference calls, facilitating mailings and other project-related administrative tasks.
• Oversee the processing of protocols through DFCI Institutional Review Board (and other institutions’ IRBs) when appropriate.
• Collaborate with the DFCI Clinical Trials Office (CTO), the Office for Human Research Studies (OHRS), and the Office of Data Quality (ODQ) to fulfill local and federal requirements governing human clinical trials.
• Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.
• 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.
• Oversee and coordinate the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials.
• In collaboration with clinical research administration and grant managers, may maintain, monitor and reconcile all study and related grant finances. These may include budget development, expenditure tracking, procurement, salary offset worksheets and staffing.
• Collaborate with the DFCI CTO, and DF/HCC ODQ to develop study forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials
• Oversee the subject enrollment, protocol treatment and follow-up care processes for protocol patients.
• Oversee registration of protocol patients with ODQ or OnCore policies as outlined in protocol.

REGULATORY & COMPLIANCE:

• Assume responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance.Â
• 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. Â

DATA MANAGEMENT & CLINICAL TRIAL MONITORING:Â

• Responsible for development and maintenance of study-related databases with directives and prepare program/study-related reports as needed.
• Assume 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.
• Submit 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.
• Develop 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.
• Previous supervisory experience required

SKILLS, ABILITIES, AND KNOWLEDGE REQUIRED:

• Must be able to perform day to day responsibilities independently with minimal supervision from manager.
• Must be somewhat proficient in the following: identifying complex regulatory scenarios that require consultation, clinical trials start-up, active and close out phases, clinical research local policy and federal regulation.
• Must have some proficiency 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.
• Experience in protocol development, data compilation and analysis.
• Skilled at developing tracking systems to ensure timely data management by the clinical research staff.
• 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.

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.

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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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