Clinical Research Manager - Breast Oncology Clinical Trials

This Clinical Research Manager (CRM) position 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.

About the Role

The Clinical Research Manager, in collaboration with the program’s physicians and research nursing staff, is 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. This position is hybrid with two or three 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).

Responsibilities

• Oversee the disease group’s clinical trial portfolio and all related regulatory, compliance, and performance metrics requirements.
• Process protocols through DFCI Institutional Review Board (IRB) 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 act 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 study 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, maintain, monitor, and reconcile all study and related grant finances, including budget development, expenditure tracking, procurement, salary offset worksheets, and staffing.
• Assist the principal investigator in preparing manuscripts for publication.
• Collaborate with the DFCI CTO and DF/HCC ODQ to develop study forms, database information, and 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 and pharmaceutical company as outlined in protocol.
• Responsible for data entry of study-specific activity, including but not limited to subject visit tracking, monitor visits, external site enrollment, amendments, and receipt of Safety Reports into the Clinical Trial Management System.
• Review, approve, and report on data entry completed by supervised research staff in the Clinical Trial Management System.
• Assume responsibility for essential document compliance for the entire portfolio and implement systems to monitor and ensure regulatory document collection and maintenance compliance.
• Assume responsibility for all clinical trial reporting requirements, including safety events, annual approvals, and deviations.
• Implement systems to monitor portfolio compliance and transition the disease group from paper to electronic regulatory binders.
• Assume responsibilities for data management and compliance for the entire portfolio, maintaining schedules and procedures necessary for timely and complete data collection.
• Regularly report data compliance status to key stakeholders and implement corrective action to maintain data compliance when necessary.
• Submit required progress/tracking reports to key stakeholders when applicable.
• Responsible for the recruitment and oversight of all research staff, ensuring completion of required mandatory and ongoing training.
• Develop and oversee a program-specific onboarding and orientation process and conduct annual performance evaluations and competency assessments of research staff.
• Develop a standard supervision schedule with research staff, including periodic individual and group supervision meetings, and document all applicable meetings.
• Communicate all personnel concerns to their immediate supervisor and to DFCI HR partner for appropriate response and follow-up.

Supervisory Responsibilities

• Supervise study management staff, including clinical research coordinators, students, volunteers, and other research assistants.

Qualifications

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

Skills

• 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.
• Computer skills including the use of Microsoft Office and working knowledge of Livelink, EPIC, and OnCore applications.
• Proficient in identifying complex regulatory scenarios that require consultation, clinical trials start-up, active and close-out phases, clinical research local policy, and federal regulation.
• Proficient in managing personnel issues and providing critical feedback to supervisees.

Pay

$77,400.00 - $102,800.00