Regulatory Affairs Specialist 2
Comprehensive Cancer Center - Clinical Trial Operations
MP 24 $66,000-$113,000 with sign on bonus potential
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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.
Serves as the primary specialist on regulatory affairs processes for clinical research studies. Maintains knowledge of changing regulations and policies governing clinical research and assesses the impact of such changes on the regulatory affairs department. Manages, implements, and evaluates all aspects of regulatory activities and strategies including submissions and facilitation of responses at time of study initiation, execution/maintenance and close out. Explains regulations, policies and procedures to guide others on regulatory and compliance matters. Creates reports and makes recommendations based on analysis of the protocol and knowledge of clinical trials, operations, and ICH Good Clinical Practices, federal regulations, and institutional processes. Ensures study protocol submissions, reviews and reporting requirements are met per ICH/GCP, applicable federal regulations, and institutional and sponsor policies and procedures. Oversees the maintenance of attributable, legible, contemporaneous, original, accurate and complete regulatory documentation to substantiate the essential documents for clinical research trials. Identifies instances of noncompliance and deviations from the protocol and regulatory requirements, evaluates each instance to determine appropriate corrective and preventative action, and drafts reports for submission to the appropriate parties and committees. Assesses regulatory activities program wide and identify areas for improvement or that require correction and provides recommendations, as needed. Collaborates with Investigators and Regulatory Managers to prepare and execute corrective and preventative action plans and ensure implementation and adherence to stated plan. Provides input to the Quality Education Unit to design Regulatory Specialist trainings and continuing education. Initiates preparation for interim monitoring visits, internal audits and external audits/inspections for highly complex clinical research studies. Monitors, interprets, applies, and communicates new and revised federal and state regulations, and local/institutional policies and guidance. Maintains established departmental policies and procedures, objectives, quality assurance programs, safety, and compliance standards. Prepares written documentation as required by the profession and the department; maintains, distributes, analyzes, and projects information for required records, reports and statistics as directed. Assists in mentoring and training of Regulatory Affairs Specialists I. Performs other duties as assigned.
Required Education and Experience
Bachelor’s degree in life sciences or other health related discipline required and a minimum of three (3) years’ experience in regulatory affairs support.
Required Skill/Ability 1:
Interprets and applies advanced knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, institutional and sponsor practices, standards, policies, and procedures at the unit/functional level. Experience interpreting highly complex clinical trial protocols.
Required Skill/Ability 2:
Professionalism, maturity, good judgment, mentorship and ability to work with confidential material and protected health information. Excellent interpersonal, oral, and written communication skills and ability to work effectively with a wide variety of external and internal stakeholders. Ability to mentor, present and teach.
Required Skill/Ability 3:
Independent, organized worker capable of multitasking and remaining focused in a fast-paced environment with competing priorities. Takes initiative to plan, research and manage multiple complex studies using advanced understanding of clinical research processes and procedures across the study lifespan.
Required Skill/Ability 4:
Analytical in nature. Decisions are guided by factors including expertise, context, independent judgment and clear to obscure guidelines and policies and can impact the areas of which they are accountable. Works under minimal supervision and understands when to inform others of developments or issues with a specific study.
Required Skill/Ability 5:
Proficiency in Microsoft Office Suite (Word, Excel, Outlook, etc.); Internet skills.
Preferred Education, Experience and Skills:
Experience in clinical research in an academic setting preferred. Experience in a Cancer Center setting preferred.
Preferred Licenses or Certifications:
SOCRA/ACRP/RAPs (or equivalent) certification preferred.