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Clinical Trials Education and Training Specialist - Regulatory and Operations

Job Description

Job ID:
39218

Location:
10 Brookline Place West, Brookline, MA 02445

Category:
Clinical Research

Employment Type:
Full time

Work Location:
Hybrid: 2-3 days onsite/week

Overview

The Clinical Trials Office (CTO) Education & Training Specialist I position is responsible for the collaborative development, implementation and oversight of the education and training curriculum that will support and provide the necessary skill sets for the DFCI Clinical Research staff to thrive and succeed in their respective clinical research roles.

This position reports directly to the CTO Director of Research Project Management, the CTO Sr. Director, and will have an indirect reporting relationship to the DFCI Office of Clinical Research. 

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.

Responsibilities

  • Collaborating with the CTO, Research Nursing, and other key stakeholders to identify the educational and training needs for the DFCI Research staff, to develop, execute and update educational materials and resources and to conduct live and online educational sessions.
  • Provide guidance, coaching, and resources to staff conducting clinical / operational tasks and/or regulatory tasks including multi-center and PI-initiated protocols.
  • Responsible for conducting periodic analyses to determine specific training needs for clinical research staff in collaboration with all key stakeholders
  • Develop, execute, and update a centralized onboarding and orientation training program for new Clinical Research Coordinator and Regulatory staff including Regulatory Coordinators, Research Project Managers, and other research staff as applicable
  • Facilitates ongoing training for Clinical Research Staff in conjunction with the Clinical Research Leadership
  • Identifies, selects, and/or develops appropriate training programs, including the selection or design of appropriate training tools and resources
  • Assists Associate Director and CTO Directors with writing and reviewing DFCI education and training standard operating procedures
  • Responsible for developing the systems, tools, and infrastructure needed for clinical research core activities
  • Prepares and presents status reports and training metrics to key stakeholders. Depending on project needs, these reports may include information about project timelines, status of deliverables, and/or resources requirements
  • Assist CTO Directors in tracking staff workloads, providing resources, tools, templates, guidance, and feedback to improve efficiency and quality where possible.
  • Update and maintain DFCI manuals and guidance to enhance skills and competences across research teams.
  • Collaborate with CTO and DF/HCC leaders to coordinate the CTO’s Clinical Research Pipeline Program for interns internal and external to DFCI working with stakeholders and collaborators of research administration, disease programs, and DF/HCC departments.
  • Assist CTO leadership and staff on projects directly or indirectly related to education and training as assigned.

Qualifications

Minimum Education: 

  • Bachelor's degree required.

Minimum Experience:  

  • At least 3 years of experience with clinical research training or related experience required.
  • Experience in an academic institution and proven history of demonstration of success in past positions is preferred.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

  • Basic knowledge of regulatory affairs, research ethics and an overall understanding of the conduct of clinical research.
  • Working understanding of DF/HCC SOPs and applicable federal and local regulations/policies
  • Excellent organizational skills and attention to detail
  • Excellent written and verbal communication and interpersonal skills
  • Critical thinking skills and an appropriate level of good professional judgment
  • Excellent ability to work independently and balance multiple projects and tasks simultaneously
  • Strong ability to both work as a member of and effectively and proactively leads teams
  • Ability to identify problems or potential obstacles and escalate appropriately
  • Ability to independently perform routine tasks related to the CTO’s core Education & Training infrastructure services with moderate supervision

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 equally committed to diversifying our faculty and staff.  Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse 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.

EEOC Poster

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