OSITION DESCRIPTION

GENERAL SUMMARY OF POSITION:

Under the general direction of the Director, Office of Clinical Research, or designee, the CCTS Education Specialist will play an active role in defining, developing, facilitating and tracking education efforts related to clinical research at UMass Medical School.  The CCTS Education Specialist will develop sessions, either independently or in collaboration with subject matter experts, to deliver education and training to support the ongoing needs of the research community.

The CCTS Education Specialist will manage and track efforts within UMass Worcester Medical School to support the enhanced understanding of and compliance with applicable regulations, guidance, and policies guiding clinical research, including OHRP regulations and guidance, NIH policy and guidance, FDA regulations and guidance, GCP guidance and UMMS institutional policies and will collaborate with others within the CCTS to track the effectiveness of Education and Outreach activities. The CCTS Education Specialist will also actively participate in the co-development/implementation of cross-institutional educational efforts at Clinical and Translational Science Award institutions.

The CCTS Education Specialist will also be responsible for the external-facing presence of the CCTS Human Research Protection Program, including guiding content of the CCTS Human Research Protection Program website and associated components.

MAJOR RESPONSIBILITIES:

• Develop a comprehensive clinical research education program for the UMass Worcester Medical School
• Working both independently and in collaboration with other stakeholders to develop and deliver educational programs on a wide range of topics for the clinical and human subjects research community, on topics such as International Council on Harmonization (ICH), Good Clinical Practice (GCP) and Food and Drug Administration (FDA)
• Track efforts related to clinical and human subjects research education and support management of individual research education requirements, including CITI and other designated requirements
• Facilitate Clinical Research Professionals Group activities, including monthly meetings and communication to the clinical research community on events and items of interest to the conduct of clinical research at UMass Medical School
• Guide content for the CCTS Human Research Protection Program website, ensuring that content is current and updated, including information on clinical and human research education opportunities on a regional and national level
• Coordinate with key individuals within the UMass CCTS Human Research Protection Program to generate quarterly HRPP newsletter.
• Represent CCTS in workgroups and efforts related to the CCTS and the UMass CCTS human research protection program
• Keep informed of new regulations, requirements and trends on national and international levels
• Survey best practices and approaches for education and communication for Clinical and Human Research at peer institutions
• Collaborate with other staff on evaluation of educational programs
• Collaborate with colleagues at fellow CTSA institutions to develop CTSA-wide GCP training and coordinator competency materials and certification platforms as needed.
• Perform other duties as required

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in Education, Nursing, a related field, or equivalent experience
• 5 Year of experience in clinical research or health education
• Prior experience in an academic health center or hospital preferred
• Working knowledge and understanding of federal, state regulations and guidance related to clinical research
• Experience in conducting individual and group (small and large) education and training
• Ability to work independently on multiple projects
• Superior communication, organizational and interpersonal skills, and attention to detail
• Ability to problem-solve and work under pressure in a deadline-driven environment
• Strong computer and software skills (presentation and tracking)

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SUPERVISION RECEIVED:

Director, Office of Clinical Research or designee

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SUPERVISION EXERCISED: 

None

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ENVIRONMENTAL WORKING CONDITIONS:

Usual office environment

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PREFERRED QUALIFICATIONS:

• Master’s degree
• Certification in clinical research (CIP, SOCRA, ACRP or equivalent)
• Experience with Huron eResearch platform
• Experience with IRB processes and procedures

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