Clinical Research Manager II - Pediatric Stem Cell Transplant

About the role

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.

Responsibilities

• Oversee the 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
• 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 these 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, may 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 to 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
• If applicable for coverage or trial assignments, be 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
• Be responsible for reviewing, approving, and reporting on data entry completed by supervised research staff in Clinical Trial Management System, including but not limited to Subject Visit Tracking for subject-specific visits, time and effort spent on study-specific activities and other administrative tasks, etc.
• Assume responsibility for essential document compliance for entire portfolio; implement systems to monitor and ensure regulatory document collection and maintenance compliance
• Assume responsibilities for all clinical trial reporting requirements: safety event, annual approval, deviations, etc.; implement systems to monitor portfolio compliance
• Be responsible for the disease group's transition from paper to electronic regulatory binders and maintain per DFCI CTO standards
• Assume responsibilities for data management and compliance for entire portfolio; maintain schedules and procedures necessary for timely and complete data collection
• Regularly report data compliance status to key stakeholders (DFCI PI, study Sponsor, DFCI CTO); implement corrective action to maintain data compliance when necessary
• Submit required "progress / tracking" reports to key stakeholders, when applicable
• Be responsible for the recruitment and oversight of all research staff
• Ensure that all staff complete required mandatory and ongoing training in a timely manner
• Develop and oversee a program specific on-boarding 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 meeting; develop agenda, take attendance and document all applicable meetings
• Communicate all personnel concerns to their immediate supervisor and to DFCI HR partner for the appropriate response and follow up

Qualifications

• Bachelor's Degree required, with a minimum of 5+ years of related experience, or Master's Degree with 5 years related experience
• Must be able to perform day to day responsibilities independently with little or no supervision from manager
• Very proficient knowledge of and ability to execute clinical trials start-up, active and close out phases
• Very proficient knowledge of clinical research local policy and federal regulation
• Ability to easily identify complex regulatory scenarios and independently develop viable solutions to present to supervisor
• Very proficient in the ability to manage personnel issues and to provide critical feedback to supervisees, when applicable
• 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

Supervision

Supervises study management staff, including clinical research coordinators, students, volunteers, and other research assistants. Number of direct reports: 6-10. May have contact with pediatric patients and families/guardians.

Pay

$94,500.00 - $113,700.00