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Clinical Research Regulatory Specialist

2 months ago

Southfield, Michigan, United States Revival Research Institute, LLC Full time

The Clinical Research Regulatory Specialist plays a crucial role in managing the regulatory aspects of clinical research protocols on a daily basis. This position is tasked with overseeing all phases of study initiation, modification submissions, ongoing reporting, and finalization to the Institutional Review Board (IRB) and other pertinent regulatory bodies.

Key Responsibilities:

  • Oversee daily regulatory functions and the workload of the regulatory team, planning resource requirements and strategizing for future growth.
  • Provide regulatory guidance for research initiatives and ensure the upkeep of all necessary regulatory documentation.
  • Support research teams with regulatory start-up processes for various clinical trials.
  • Collaborate with study teams to offer on-demand regulatory management for active clinical trials.
  • Ensure timely regulatory submissions to align with project deadlines.
  • Maintain Standard Operating Procedures (SOPs) and guarantee adherence to procedural standards.
  • Identify opportunities for program enhancements and spearhead improvement initiatives within the team, including technological solutions; explore ways to broaden these solutions to study teams.
  • Coordinate with relevant departments to resolve regulatory-related quality and compliance issues.
  • Assist in developing standard training requirements related to regulatory matters and provide ongoing education for investigators and research staff.
  • Collaborate with Quality Assurance to conduct internal audits and quality assurance evaluations on regulatory documentation as necessary.
  • Act as a liaison with appropriate personnel, departments, and external entities regarding clinical trial regulatory operations.
  • Conduct routine audits of research documentation, ensuring:
    • Proper informed consent from participants
    • Effective screening and recruitment strategies
    • Compliance with the IRB-approved study protocol
    • Accurate data collection and entry
    • Protection of participants' privacy and confidentiality
    • Timely reporting of adverse events and protocol deviations
  • Assist sites with quality assurance efforts, including the creation of corrective and preventive action plans (CAPA) and notes to file (NTF).
  • Submit protocol deviations, adverse events (AE), and severe adverse events (SAE) to the IRB after consultation with the Director of Clinical Research.
  • Ensure the receipt and proper filing of acknowledgments for deviations, AEs, and SAEs.
  • Willingness to travel to local sites for monitoring purposes if necessary.
Qualifications:
  • Bachelor's degree in Clinical Health Science, Healthcare Administration, or a related discipline.
  • Minimum of 2 years of experience in Clinical Research is preferred.
  • Thorough and current understanding of Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and FDA regulations.
  • Exhibit strong decision-making abilities, sound judgment, attention to detail, and follow-through skills.