The Clinical Trials Monitor helps to ensure compliance of the clinical research enterprise with all related regulatory policies and guidelines, including federal, state, local, as well as the policies and procedures outlined by the Dana-Farber Cancer Institute and Dana-Farber Harvard Cancer Center (DF/HCC) consortium. Under the direction of Clinical Trials Office Leadership, s/he will assist in the design, development, implementation, and conduct of an effective monitoring program in accordance with Good Clinical Practice, institutional policies and procedures, and research protocols. The Clinical Trials Monitor will ensure that, for those clinical trials assigned for monitoring, the appropriate and required monitoring tasks and related activities occur as outlined in the monitoring plan and in compliance with all related regulatory standards. Monitoring will be performed through a combination of remote data review and onsite monitoring visits; therefore, a willingness and ability to travel occasionally is required. The Clinical Trials Monitor is responsible for multiple projects at a time, and must have strong time management skills in addition to working both independently and in a team environment. S/he will be responsible for promoting a culture of monitoring compliance and regulatory awareness within DRFCI and DF/HCC.

• Track, review, and approve all required monitoring activities for the monitoring team; e.g. interim monitoring reports, follow-up letters, and close out reports prior to dissemination to Overall PI and study teams
• Provide daily supervision of CTO monitoring personnel, including assignment of monitoring tasks and management of overall workload
• Assist in personnel decisions and hiring processes, as needed
• Coordinate development and implementation of monitoring contracts
• Communicate upcoming and ongoing monitoring assignments and expected timelines to Monitoring team. Ensure the established timelines for monitoring activities and monitoring report completion are tracked and met
• Assist the Clinical Trials Office Leadership with the oversight and training of DFCI monitoring staff, and provide ongoing guidance to help ensure consistency and compliance with DFCI monitoring standards
• Work with Clinical Trials Management Team to identify topics and assist in developing curriculum for providing training to enhance monitoring skills and competencies
• Assist in the future development of metrics tracking systems, and use these systems to monitor and assess effectiveness of the monitoring program
• Provide summaries of metrics data to the Clinical Trials Office Leadership on a regular basis
• Identify issues that interfere with effective monitoring and overall protocol performance
• Implement strategies to resolve issues in consultation with Clinical Trials Management Team
• Review proposed and active clinical monitoring study budgets, and communicate variances to the appropriate Clinical Trials Management member
• Lead / Co-Lead regular monitoring team group meetings

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Extensive knowledge of federal, state and local regulations concerning relevant research compliance areas
• Experience in the interpretation of legislation, regulations, policies, procedures, and ethical principles in research compliance are required
• The ability to translate regulations into operational policies and procedures is essential
• Knowledge of the broader research environment, including emerging regulatory trends, best practices at other institutions, conflict of interest, responsible conduct of research, and other issues is highly desirable
• Excellent communication skills and an ability to work with diverse constituencies within an academic community
• Capacity to handle multiple activities simultaneously and to effectively prioritize tasks and responsibilities
• Must be team oriented, results driven and able to motivate others
• Must be computer literate in Microsoft Office suites, including Word, Excel and PowerPoint
• Be able to travel depending on project needs

MINIMUM JOB QUALIFICATIONS:

Responsible for mentoring and providing daily supervision of the CTO Clinical Trials Monitors (3-5 FTEs) and assisting with the supervision of other DFCI monitoring personnel (10-12 FTEs). Responsible for training and orientation of new Clinical Trials Monitors and assisting with the ongoing training of the monitoring team as needed.

The role requires a bachelor's degree, with a master's degree preferred, in a field relevant to research compliance, and 5+ years of experience monitoring clinical trials, including mentoring other monitors. Prior experience as a lead monitor or supervising a monitoring team is highly desired. Experience in an academic setting, particularly collaborating with administrators, faculty, and research staff, is preferred. Candidates must have expertise in research ethics and the responsible conduct of research.

SUPERVISORY RESPONSIBILITIES:

PATIENT CONTACT: