Clinical Research Manager Pediatric Cell Therapy

Dana-Farber Cancer Institute; Brookline, Northern (MA, KY); On-site; USD 77,000 - 103,000; Full time

Job summary

Dana-Farber Cancer Institute in the Boston area is seeking a Clinical Research Manager to lead a disease group’s clinical trial portfolio, ensuring regulatory compliance and performance metrics. You will collaborate with physicians, nursing staff, and research administration to design, implement, and evaluate trial activities and budgets.

The role involves supervising research staff, coordinating regulatory filings, data quality control, and ensuring patient safety across therapeutic and

Responsibilities

• Oversight of disease group’s clinical trial portfolio and regulatory, compliance and performance metrics requirements
• Collaborate with IRBs, CTO, OHRS, and ODQ to fulfill local and federal requirements
• Identify and manage operational, logistical, and regulatory challenges
• Assist PI in protocol budgeting with Research Administration and Grants offices
• Oversee procurement, receipt, inventory and distribution of trial equipment
• Maintain study finances with grant managers and financial officers
• Assist in manuscript preparation
• Develop study forms and data quality guidelines with CTO/ODQ for PI Initiated studies / Multi-Center Trials
• Oversee subject enrollment, protocol treatment and follow-up for protocol patients
• Register protocol patients with ODQ or OnCore policies and pharmaceutical company guidelines

Job description

These positions work within the clinical research program and manage the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Trials Office. The Clinical Research Manager, in collaboration with the program’s physicians and research nursing staff, are responsible for the design, implementation and evaluation of their program’s clinical research activities (therapeutic and non-therapeutic), all related regulatory and compliance oversight, and direct supervision of their program’s clinical research staff. The Clinical Research Manager is responsible for tracking and complying with clinical trial performance benchmarks; e.g. protocol and regulatory compliance, patient safety, staff development & training and financial goals, as defined by Senior Research Leadership and the DFCI Clinical Trials Office.

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.

PRIMARY DUTIES AND RESPONSIBILITIES:

Clinical Trials Operations

• Clinical Research Managers (CRM) are responsible for the oversight of their disease group’s clinical trial portfolio and all related regulatory, compliance and performance metrics requirements.
• The CRM will oversee the processing of protocols through DFCI Institutional Review Board (and other institutions’ IRBs) when appropriate. The CRM will 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.
• The CRM will Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.
• The CRM will 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.
• Oversees and coordinates 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.
• Assists the principal investigator in preparing manuscripts for publication.
• The CRM will 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
• The CRM will oversee the subject enrollment, protocol treatment and follow-up care processes for protocol patients.
• Oversees registration of protocol patients with ODQ or OnCore policies and pharmaceutical company as outlined in protocol.

• undefined

Regulatory & Compliance

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

• undefined

Data Management & Clinical Trial Monitoring

• Assumes 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.
• Submits 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.
• Develops 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.

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusiveenvironment 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 compassionateprofessionals, 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.

EEO Poster

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).

$77,400.00 - $102,800.00