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Regulatory and Compliance Management Specialist

3 months ago

Nashville, United States Meharry Medical College Full time

The Regulatory and Compliance Management Specialist (RCMS) will ensure that the Meharry Medical College (MMC) clinical data managed under its Enterprise Data and Analytics (EDA) Division complies with industry specifications, standards, regulations, and laws. Focused on core data technologies with strong ties to application areas across campus, the EDA division collects, stores, analyzes, governs, and stewards data to drive optimal outcomes for the entire Meharry Medical College enterprise which comprises the Academic enterprise, the Business enterprise, the Clinical enterprise, and the Research enterprise. The RCMS will spearhead the development and oversight of all regulatory, compliance, quality assurance, governance, and educational activities under the Clinical Data Stewardship department of the EDA division. The responsibilities include management of data operations engaged in clinical research including exempt and non-exempt research with human subjects. This role requires expertise in federal laws pertaining to the contracting of research services to integrated and affiliated physicians, Common Rule (45CFR46), Food and Drug Administration (FDA) regulations, International Council on Harmonization (ICH) Good Clinical Practice Guidelines, and other relevant requirements and guidelines related to the ethical study of human research subjects.
The RCMS must possess a commitment to advancing systems research goals in promoting the culture of conscientiousness for the ethical conduct of human subject research throughout pertinent systems. This position serves as a resource providing guidance to the MMC research community on regulations that govern the areas of conflict of interest, human subject research, research misconduct, and responsible conduct of research, and ensures appropriate review/ routing/ approval of all system research activities for required approvals.
The results-driven RCMS will collaborate with internal and external stakeholders on compliance-related issues, and will review operational practices, documentation and procedures; create and enforce compliance plans; implement and develop regulatory compliance strategies; conduct compliance audits; and perform regulatory risk management. We are seeking a RCMS to.

Daily Operations

•Follow requirements of applicable national and international regulations, and assist data professionals and staff in understanding how to interpret these regulations.
•Guide team in analyzing data received and preparing documentation for submission to obtain clearance or approval for a product.
•Participate in developing policies, processes, procedures, and governance policies.
•Responsible for implementation of on-prem or cloud infrastructure to ensure the whole process follows all the regulations and ensures compliance. Keep records and prepare documentation.
•Participate in product development and verify compliance with design control requirements and procedures.
•Determine appropriate regulatory requirements and strategies for company projects including both domestic and foreign activities and provide regulatory consultation to internal and external entities.
•Interview executives, managers, and employees to determine compliance-related priorities.
•Review pertinent documentation, processes, and practices.
•Monitor reports and data quality responsiveness, identify and resolve problems, and determine action plans in consultation with the required offices.
•Provide ongoing education and training support to faculty and staff on regulatory processes. Oversee and ensure faculty or other staff comply with regulatory measures on internal or external portals.
•This position will be a critical resource and subject matter expert regarding the hosting and execution of inspections, whether they be self-inspections or by external entities
•Ensure regulatory changes are reviewed each day, draft overviews and change analysis statements to ensure updates are communicated/cascaded to relevant parties
•Interact with legal, risk and compliance, development and analytics departments, federal agencies, industry organizations, and interdepartmentally and external departments at all levels.
•Develop and enact regulatory compliance strategies.
•Coordinate regulatory compliance procedures across organizational structures.
•Monitor compliance and facilitate interventions to manage risks.
•Perform compliance audits and compile reports.
•Document compliance-related processes and maintain records.
•Keeping abreast of regulatory changes and developments in the regulatory environment.
•Performs other related duties as assigned.

Required Skills

•Extensive knowledge of industry regulations and governing laws pertaining to clinical data and operations.
•Proficiency in office and compliance management software.
•Exceptional analytical, investigative, and organizational skills.
•Knowledge of data privacy and security concepts, practices, and technologies.
•Knowledge of U.S. and international data privacy regulations especially related to protected health information
•Demonstrate the ability to lead complex projects that include clinical studies.
•Demonstrate ability to consistently exercise sound judgment and initiative in complex clinical and business problems
•Proven ability to distill complex business issues and provide logical, compelling, and clear plans for action
•Self-starter, self-motivated, high level of initiative within a fast-paced, constantly evolving data management environment.
•Excellent diplomacy, facilitation, interpersonal and communication skills
•Ability to demonstrate collaboration with diverse stakeholder groups, including research, clinical, and administrative, faculty, and staff
•Ability to think clearly, analyze quantitatively, problem-solve, scope technical requirements, and prioritize tasks.
•Ability to communicate ideas and execution plans clearly in technical and non-technical environments.
•Display an elevated level of professionalism, and high moral and ethical standards in all dealings with business associates and stakeholders.
•Excellent attention to detail.

Required Experience and Education

•Bachelor's degree preferably in Regulatory Affairs or human subject research specialization and/or 2-3 years of experience in Regulatory Affairs, Or Bachelor's degree in nursing or a related field with relevant experience, or Master's degree in Regulatory Affairs or a related field.
•An accredited qualification in regulatory and compliance assurance will be advantageous.
•Current Certification in Healthcare Research Compliance (CHRC) or Clinical IRB Professional (CIP) strongly preferred
•Experience with an institutional review board (IRB) and/or human subjects' research
•Experience writing, reviewing, developing, or implementing policies, processes, and procedures.