The Clinical Research Manager will work within the Pediatric Heme Malignancy 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, other Clinical Research Managers 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, the DFCI Clinical Trials Office and by CTIP leadership.

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 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.

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.

SUPERVISORY RESPONSIBILITIES:
Supervises study management staff, including clinical research coordinators, students, volunteers, and other research assistants.

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.

KNOWLEDGE, TECHNICAL SKILLS, AND ABILITIES REQUIRED:

• Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
• Has 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.

PATIENT CONTACT:

May have contact with patients of all ages and populations.

WORKING CONDITIONS:

Normal office environment.

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