Posted:
6/4/2024, 5:00:00 PM
Location(s):
Charlotte, North Carolina, United States ⋅ North Carolina, United States
Experience Level(s):
Junior ⋅ Mid Level ⋅ Senior
Field(s):
Legal & Compliance
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.
Website: https://mmc.edu/
Headquarter Location: Nashville, Tennessee, United States
Year Founded: 1876
Last Funding Type: Grant
Industries: Education ⋅ Higher Education ⋅ Universities