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Senior Regulatory Affairs Specialist

Company: System One
Location: New Haven
Posted on: January 27, 2023

Job Description:

Title: Senior Regulatory Affairs Specialist
Location: REMOTE
Duration: Direct Hire
Schedule: M-F 37.5 hours
Target Start Date: ASAP


Responsibilities:


  • Manages the study portfolio and independently executing regulatory activities for all types of clinical research studies across the lifecycle of the protocol from activation to closeout. The Senior Regulatory Affairs Specialist will be aware of and take a leadership role in implementing changes due to updates to regulations and policies governing clinical research and planning for the regulatory aspects of growth to support the research enterprise.
  • The Senior Regulatory Affairs Specialist is responsible for regulatory start-up of new protocols, including providing regulatory expertise in the development, preparation, submission, and management of complex federally regulated Investigator-Initiated and multisite trials.
  • Oversees and makes decisions or commitments that require interpretation and analysis of federal research regulations, Good Clinical Practice and the institution's policies and procedures.
  • Monitor workload intensity and track deadlines within their disease team's assigned portfolio and 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.

    Requirements:

    • Advanced degree and certificate in related field. Experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Experience in a Cancer Center setting. Two or more years of supervisory or mentoring experience in regulatory affairs. ORBachelor's degree in life sciences or other health related discipline required and minimum of five (5) years' experience in regulatory affairs support
    • SOCRA/ACRP/RAPs (or equivalent) certification or ability to obtain within one year of employment PREFERRED
    • Demonstrated ability to interpret and apply extensive knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations. Proven ability to interpret high acuity clinical trial protocols and manage several studies concurrently while balancing competing priorities/deadlines.
    • Ability to initiate planning, researching and management of high acuity clinical trials using superior understanding and expert knowledge of study start up activities and clinical research processes across the study lifespan. Works under minimal supervision. Understands when to inform others of developments or issues with a specific study.
    • Proficiency in Microsoft Office Suite (Word, Excel, Outlook, etc.); Internet skills.

Keywords: System One, New Haven , Senior Regulatory Affairs Specialist, Other , New Haven, Connecticut

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