Clinical Research Manager - Breast Oncology Clinical Trials

Boston While Black; Brookline (MA); Hybrid; USD 77,000 - 103,000; Full time

Job summary

Dana-Farber Cancer Institute is seeking a Clinical Research Manager to lead the Breast Oncology clinical research program, overseeing trial operations, regulatory compliance, data management, and staff development under the CTO and PI guidance.

The role is hybrid with 2-3 onsite days in Boston, MA, and allows remote days from New England states. Strong leadership, budgets, and collaboration with clinical teams are essential.

Qualifications

• Bachelor’s degree required with 5+ years of related experience.
• Must be able to function independently and have supervisory experience.

Responsibilities

• Oversee the disease group’s clinical trial portfolio and ensure regulatory, compliance and performance metrics.
• Collaborate with CTO, OHRS, and ODQ to fulfill local and federal requirements.
• Assist PI in protocol budget development and work with grants and contracts offices on reporting and accounting of funds.
• Oversee procurement, inventory and distribution of equipment for trials and related finances.
• Support manuscript preparation and data quality control for PI-initiated studies and multi-center trials.

Skills

Supervisory experience

Independent functioning

Education

Bachelor’s Degree

Tools

Microsoft Office

Livelink

EPIC

OnCore

Job description

The Clinical Research Manager (CRM) will work within the Breast Oncology 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.

This position’s work location is hybrid with 2-3 days per week onsite in Boston, MA. The selected candidate may only work remote days from a New England state (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.

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.
• 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.
• 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.
• 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.
• 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.

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.

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.

MINIMUM JOB QUALIFICATIONS

• Bachelor’s Degree required, with a minimum of 5 years of related experience preferred.
• Must be able to function independently and must have previous supervisory experience.

REQUIRED COMPETENCIES

• 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, TECHNICAL SKILLS, AND ABILITIES REQUIRED

• 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.

SUPERVISORY RESPONSIBILITIESSupervises study management staff, including clinical research coordinators, students, volunteers, and other research assistants.

PATIENT CONTACT: May have contact with patients of all ages and populations.

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.

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