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Clinical Trials Monitor

Dana-Farber Cancer Institute


Location:
Boston, Massachusetts
Date:
05/24/2017
2017-05-242017-06-23
Categories:
  • Clinical Operations
Dana-Farber Cancer Institute
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  • Research Salary

Job Details

Overview

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

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 each applicable network site IRB.  Under the direction of Clinical Trials Office Leadership, s/he will assist in overseeing the network sites’ clinical trials in their design, development, implementation, and conduct of an effective monitoring program in accordance with Good Clinical Practice, and unique network site 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 for all network sites.  Monitoring will be performed through a combination of remote data review and onsite monitoring visits; travel 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 DRCI and the network sites.

 

Responsibilities


  • At all network sites:Independently coordinate upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports.
    • 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. 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).
 
  • Assist in the development and writing of clinical trial monitoring plans for all network sites.
  • Provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.
  • Participate in regular monitoring team group meetings.
  • Coordinate the monitoring of clinical trials at network sites, including regular meetings with network site staff and troubleshooting all monitoring issues at network sites.
  • Responsible for maintaining strong partnership with all network sites clinical trials staff.
  • Responsible for assessing new network sites on capability and quality of clinical trials.
  • Assist in the training and orientation of newly hired Clinical Trials Monitors.
  • Assist in the development of monitoring best practices, standard procedures, policies and guidance documents.
  • Mentor monitoring team and conduct co-monitoring / training visits.
  • 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

Requirements

Qualifications

Regular travel required to all DFCI network locations (50% of the time with the possibility to increase).  Must have a valid driver’s license and access to reliable transportation to travel to and from the network locations.

 

Bachelor's degree in a field relevant to research compliance and 5 years of progressively responsible clinical trials experience with 3-5 years of monitoring experience. Master's degree preferred. Experience in an academic institution is preferred, especially working in collaborative efforts with upper administrators, faculty and research staff as well as research support personnel.  Must have expertise in research ethics and the responsible conduct of research. 

 

 

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, and be able to travel depending on project needs.