Clinical Trial Monitor - Regulatory
About The Position
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, the Clinical Trials Monitor 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. The Clinical Trials Monitor will be responsible for promoting a culture of monitoring compliance and regulatory awareness within DRFCI and DF/HCC. 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.
Requirements
- 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
- Ability to translate regulations into operational policies and procedures is essential
- Excellent communication skills and an
- Ability to work with diverse constituencies within an academic community
- Capacity to handle multiple activities simultaneously
- 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, and be able to travel depending on project needs
- The position requires a bachelor's degree in a field related to research compliance, along with 3+ years of clinical trials experience, including at least 1 year of monitoring experience.
Nice To Haves
- 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
- 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.
Responsibilities
- Ensure the Sponsor-Investigator and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures, including DFCI CTO Monitoring standards and guidelines
- Adhere to the protocols’ Data Safety Monitoring Plans; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates
- Monitor clinical trial progress through a combination of remote data review and on site monitoring visits. Some travel will be required
- Verify that trial data entered on the Case Report Form is consistent with patient clinical notes and other source documentation (source data verification)
- Independently coordinate upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports
- Assist in the development and writing of clinical trial monitoring plans
- Provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation
- Participate in regular monitoring team group meetings
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
