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Senior Education and Compliance Specialist, Human Research Affairs

4 months ago

Boston, United States Partners Healthcare System Full time

Come join our team and play a pivotal role in promoting and ensuring an environment where human subject research is conducted according to the highest standards

Our Team

Our Human Research Affairs Compliance and Education Office was established in June 1999 as the Quality Assurance/ Quality Improvement (QA/QI) Program within the Office of Human Research Affairs at Mass General Brigham. We provide education and support to our research community and conduct both routine and for-cause compliance audits of human subject research studies across all our institutions. We ensure compliance and optimal conduct of human research with relevant federal, state, and local regulations, Good Clinical Practice, and institutional policies. We collaborate closely with our clinical research investigators and staff, our Institutional Review Board Office (IRB), and Research Compliance offices. Our team is also responsible for oversight of Clinical Trials.gov registration and reporting by investigators across our system.

Role Overview

The Senior Education and Compliance Specialist will develop and implement quality system-wide human research education initiatives and serve as the Protocol Registration and Results System (PRS) administrator for ClinicalTrials.gov registration and results reporting for Mass General Brigham Investigators.

This role is responsible for the knowledge and application of research regulatory requirements, quality assurance/quality improvement, and health sciences research to advance our organization's mission. This role requires comprehension of research study design, excellent judgment, and decision-making in applying federal requirements to novel research constructs and incorporating those into educational initiatives. The ideal candidate will have a passion for creating engaging and effective learning experiences, a strong understanding of instructional design principles, and the ability to work collaboratively with stakeholders and subject matter experts to develop high-quality training materials.

This role will also interpret NIH, FDA, International Committee of Medical Journal Editors (ICMJE), and other federal requirements along with our organization's policies to make independent decisions regarding federal registration and results reporting of clinical trials critical for our compliance with federal law and regulations.

Principal Duties and Responsibilities

* Oversee the development and implementation of quality system-wide human research education initiatives through partnership and collaboration with representatives from our Member entities.
* Support the development of strategy and handle implementation for current and future system-wide clinical research education programs
* Assist in the management of our organization's Education Advisory Committee - working with our Research Compliance Office and clinical research representatives from each entity to create and coordinate programs and subcommittees.
* Work with subject matter experts (SMEs) and conduct thorough needs assessments to identify learning gaps, objectives, target audience, and training requirements across all of our entities to meet the need for enterprise-wide clinical research education.
* Use evidence-based practices to design, develop, and deliver instructional materials, including eLearning courses, instructor-led training, videos, and other multimedia content
* Implement instructional strategies and knowledge transfer solutions for instructor-led, web-based, virtual classroom, mobile, online, and blended learning delivery
* Create and edit multimedia elements, such as graphics, animations, and videos, to enhance the learning experience
* Apply adult learning and design principles to create engaging learning activities, course content, material/multi-media
* Develop storyboards, scripts, and outlines for training materials to guide the development process
* Design innovative, engaging, and effective SCORM-compliant courses
* Monitor the effectiveness of implemented education initiatives and develop and implement improvement strategies to enhance learner's experiences
* Produce course outlines or other educational material based on program objectives to system-wide affiliates, investigators, etc.
* Regularly assess education offerings at external academic research institutions to compare them with our organization's offerings.
* Assist with the development, implementation, and maintenance of electronic systems to support ongoing Compliance and Education Office activities
* Partner with our Digital Team to develop new and enhance existing modules and/or forms in the Research Electronic Data Capture (REDCap) system
* Remain current with human research training requirements and trends in clinical research to ensure the human research education program meets the needs of our research community
* Assist with the development and maintenance of the C&E Office department website and act as the Clinicaltrials.gov PRS Administrator
* Assist with the development, production, and distribution of the C&E Office communications about C&E and HRA activities and education
* Act as an education and compliance expert concerning ClinicalTrials.gov and the corresponding federal regulations, Institutional Review Board (IRB) requirements, and our policies and procedures. Develop and coordinate procedures and programs to enhance investigator understanding and compliance with ClinicalTrials.gov regulations and requirements.
* Review new protocols and identify which protocols require registration in accordance with FDAAA-801, NIH, CMS, International Committee of Medical Journal Editors (ICJME), or other policies or regulations.
* Work jointly with other departments such as IT to enhance existing ClinicalTrials.gov notification systems and develop reports/metrics/tracking mechanisms to review, and monitor records for compliance.
* Design and implement a communication plan for facilitating researchers' compliance with ClinicalTrials.gov registration and reporting requirements. Notify investigators of non-compliance and raise persistent non-compliance to HRA leadership.
* Identify gaps in knowledge; develop, implement, and evaluate educational programs and materials aimed at enhancing the efficiency and compliance of ClinicalTrials.gov registrations and results reporting at our institutions.
* Generate and maintain internal policies and SOPs intended to forge institution-wide compliance with ClinicalTrials.gov. This will include the development of recommendations for corrective actions and ensuring appropriate follow-up.
* Interact with appropriate entities or agencies to resolve ClinicalTrials.gov-related compliance problems.
* Serve as a Liaison with NIH ClinicalTrials.gov team to support ClinicalTrials.gov across our organization
* As appropriate, participate in the National Clinical Trials Registration Taskforce and other ClinicalTrials.gov conferences, meetings, and working groups.
* Provide outstanding customer service to investigators and research teams in response to access requests, password reset requests, requests for training or assistance in updating records, requests for clarification, and resolution of problems.
* Use/s Mass General Brigham's values to govern decisions, actions, and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation, & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement, & Personal Growth, Teamwork & Collaboration
* Other responsibilities as assigned

Qualifications

* BS required; Master's degree in related field preferred (e.g., M.Ed., MS, MSN, MSW, MPH, MPA, MSCI);
* Minimum of 3-5 years of proven experience in a research setting with exposure to research protocols and knowledge of related regulations, along with knowledge of curriculum development, Learning Management Systems, and adult learning principles
* Proficient in the full suite of Microsoft Office and the ability/affinity to learn new technology applications.
* A combination of education and experience may be substituted for requirements.

Skills, Abilities, Competencies

* Possess strong interpersonal skills to effectively connect with cross-functional teams, including staff at all levels of the organization
* Ability to successfully negotiate and collaborate with others of different skill sets, backgrounds, and levels within internal and external individuals associated with our organization
* Excellent verbal and written communication skills, including public speaking.
* Strong analytical, critical thinking, problem-solving, and negotiation skills
* Ability to effectively handle multiple, simultaneous projects and establish priorities
* Ability to be flexible and adapt to shifting priorities
* Ability to effectively conduct meetings, both formal and informal
* Excellent time management skills
* Requires minimal direction from leadership and possesses the ability to learn quickly