Clinical Research Manager II - Pediatric Stem Cell Transplant

The Clinical Pediatric Clinical Research Manager II provides leadership for pediatric clinical research operations and oversees the research team in the execution of clinical trials in accordance with Good Clinical Practice (GCP), under the direction of the Principal Investigator and the Clinical Trials Office. This role is responsible for managing the day-to-day conduct of therapeutic and non-therapeutic studies while ensuring high standards for quality, compliance, and patient safety.

Working closely with physicians, research nursing staff, and other program partners, this position supports the planning, implementation, and evaluation of clinical research activities across the program. The manager directs regulatory and compliance efforts, supervises clinical research personnel, and helps ensure studies are conducted efficiently and in alignment with institutional, sponsor, and regulatory requirements.

The Clinical Research Manager II is also accountable for monitoring and achieving key performance expectations, including protocol adherence, regulatory compliance, patient safety outcomes, staff training and development, and financial targets established by senior research leadership and the Clinical Trials Office.

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.
• 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…