Overview
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.
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:
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
Pay Transparency Statement
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).
$98,900.00 - $108,400.00