Compliance and Regulatory Subject Matter Expert SME
Compliance and Regulatory Subject Matter Expert SME
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Salary Not Disclosed
1 Vacancy
Job Description
The Compliance and Regulatory Subject Matter Expert SME ensures that the School of Medicine SOM adheres to the highest standards of compliance and regulatory oversight in research administration. This role provides authoritative guidance on federal state and institutional regulations governing clinical and observational research safeguarding the integrity and ethical standards of SOMs research activities. Core responsibilities include interpreting complex regulatory requirements advising on policy implementation and conducting compliance reviews. The SME serves as a proactive resource for departments and research administrators providing insights and training on topics such as human subjects research data security conflict of interest and sponsorspecific requirements. In collaboration with Pre/PostAward SMEs the Compliance and Regulatory SME develops strategies to mitigate risks and enhance compliancerelated processes aligning them with institutional priorities. Through continuous monitoring education and consultation this role empowers research teams to conduct innovative research while maintaining compliance and regulatory excellence
Required Qualifications Competencies And Experience
Bachelors degree in a relevant field (e.g. Business Administration Research Administration Public Health or related area). Minimum of five years of experience in research administration with a focus on compliance and regulatory affairs. Familiarity with a variety of funding sources and mechanisms including NIH industrysponsored clinical trials and other federal or private grant funding. Demonstrated ability to provide guidance and training on policies and procedures for developing and administering contracts and grants. Strong understanding of compliance requirements and the ability to assist in ensuring adherence to federal state and institutional regulations. Excellent analytical and organizational skills with experience in financial protocol development and policy implementation. Strong communication and interpersonal skills to effectively collaborate with internal and external stakeholders.
Preferred Qualifications Competencies And Experience
Masters degree or higher in a related field. Certification in Research Administration (e.g. CRA CPRA . Experience managing complex grants or clinical trial funding.
Required Experience:
Staff IC
Employment Type
Full Time
