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Regulatory Compliance Specialist with Regulatory Expertise
1 week ago
Overview:
The Senior Regulatory Compliance Specialist position at Houston Methodist Research Institute plays a pivotal role in ensuring regulatory compliance across various clinical research studies. Reporting to the Manager or Director, this specialist will lead, coordinate, and perform study-specific regulatory processes, maintaining strict adherence to Good Clinical Practices (GCP) and local, state, and federal laws, regulations, guidance, policy, and procedure.
Responsibilities:
- Regulatory Affairs Coordination: Collaborate with cross-functional teams to ensure cohesive operations within the department.
- Training and Education: Assist in training regulatory personnel on regulatory and safety reporting regulations, processes, and procedures.
- Documentation Management: Develop and maintain documents required for investigational drug trials, research protocols, and IRB submissions.
- Communication and Liaison: Interface with governmental agencies and sponsor organizations to facilitate project/product advancements.
- Quality Assurance: Conduct internal reviews and audits to ensure regulatory form compliance and provide routine updates to the Regulatory Compliance Manager.
Required Skills and Qualifications:
- Educational Background: Bachelor's degree or higher; Master's degree preferred.
- Experience: Five years of experience in relevant research program experience.
- Certifications: RAC - Regulatory Affairs Certifications (RAPS), CCRC - Certified Clinical Research Coordinator (ACRP), CCRP - Certified Clinical Research Professional (SOCRA).
About Houston Methodist Research Institute:
Houston Methodist Research Institute is a premier institution dedicated to translating laboratory discoveries into new diagnostics, therapies, and treatments. With over 1,500 staff and trainees, 284 principal investigators, and more than 570 ongoing clinical trials, the institute provides a dynamic environment for innovation and growth.
