Clinical Research Manager - Pediatrics CTIP

Dana-Farber Cancer Institute•Brookline, MA

About The Position

Clinical Research Manager, Pediatrics CTIP – Dana-Farber Cancer Institute The Clinical Research Manager (CRM) supports the Pediatrics CTIP clinical research program and leads the day-to-day management of the research team in the conduct of therapeutic and non-therapeutic clinical trials in accordance with Good Clinical Practice (GCP). Working under the auspices of the Principal Investigator and in partnership with the Clinical Trials Office (CTO), the CRM collaborates closely with program physicians and research nursing to plan, implement, and evaluate clinical research operations, ensuring high-quality execution, regulatory integrity, and patient safety. This role provides comprehensive regulatory and compliance oversight across the trial lifecycle and directly supervises and develops clinical research staff. The CRM is accountable for tracking and meeting clinical trial performance benchmarks established by Senior Research Leadership and the DFCI CTO, including protocol and regulatory compliance, patient safety, staff training and development, and financial/operational goals. 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.

Requirements

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.
Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
Experience in protocol development, data compilation and analysis.
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.

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.
If applicable for coverage or trial assignments, responsible for data entry of study-specific activity, including but not limited to subject visit tracking, monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed.
Responsible for reviewing, approving, and reporting on data entry completed by supervised research staff in Clinical Trial Management System. The data entry oversight may include, but is not limited to, Subject Visit Tracking for subject-specific visits, time and effort spent on study-specific activities and other administrative tasks, etc.
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.