Title: Regulatory Affairs Specialist 2: Remote Position with Sign on Bonus Potential
Company: Yale Cancer Center Clinical Trials Office
Reporting to the Regulatory Manager, the Regulatory Affairs Specialist 2 plays a key role in the research and treatment mission of the Yale Cancer Center Clinical Trials Office (“CTO”) by managing the study portfolio and independently executing regulatory activities for clinical research studies across the lifecycle of the protocol from activation to closeout. This role is responsible for the direct oversight and execution of regulatory activities supporting clinical studies based on knowledge, analysis and interpretation of institutional policies, federal regulations, and Good Clinical Practices (GCP). The Regulatory Affairs Specialist 2 anticipates and tracks changes in regulations and policies governing clinical research and assesses the impact of such changes on the regulatory affairs department. The Regulatory Affairs Specialist 2 autonomously navigates the regulatory review and approval processes for clinical research by compliantly completing institutional, sponsor and federal research requirements. Additionally, this role provides regulatory expertise and advisement guidance on procedural, documentation and reporting requirements related to regulatory affairs. Collaborating directly with investigators, sponsors, and other key stakeholders within Yale CTO, as well as colleagues across the research enterprise, this role participates in the advancement of critical strategic objectives that promote effective, efficient, and compliant management of Cancer Center clinical research studies. The Regulatory Affairs Specialist 2 will independently monitor their workload intensity and track deadlines to ensure prompt submission and/or completion and proper regulatory reporting and compliance deliverables are met, including recording and reporting key performance metrics for CTO leadership and departmental stakeholders. The Regulatory Affairs Specialist 2 engages critical thinking skills in the application of expert knowledge and experience to achieve desired regulatory outcomes.
The Regulatory Affairs Specialist 2 mentors Regulatory Affairs Specialist 1
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SOCRA Exp: 5/1/2023