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Regulatory Coordinator

2 months ago

Southfield, United States Revival Research Institute, LLC Full time

The Regulatory Coordinator is responsible for overseeing the day-to-day regulatory management of all types of clinical research protocols. The position will manage all aspects of study start-up, modification submissions, continuous reporting, and study close-out to the Institutional Review Board (IRB) and any relevant regulatory agencies.

Primary Responsibilities:

  • Manage day-to-day regulatory operations and workload of regulatory team, plan resource needs and strategize growth.
  • Provide regulatory support for research programs and oversee maintenance of all required regulatory documents.
  • Provide regulatory start-up support for research teams for all types of clinical trials.
  • Partner with study teams to provide ad hoc regulatory management for ongoing clinical trials.
  • Oversee timely regulatory submissions to meet project timelines.
  • Maintain Standard Operating Procedures (SOPs) and ensure procedural compliance.
  • Identify program improvement opportunities and lead improvement efforts within team, including technology solutions; identify opportunities for expanding solutions to study teams.
  • Coordinate with appropriate departments to address regulatory-related quality and compliance matters.
  • Assist with the development of standard regulatory-related training requirements and with ongoing education and training for investigators and research personnel.
  • Work with Quality Assurance to perform internal audits and quality assurance reviews on regulatory files, as needed.
  • Liaise with appropriate personnel, departments and outside entities on clinical trial regulatory operations.
  • Performing routine audits of research documentation such as
    • proper informed consent of participants
    • proper screening and recruitment methods
    • adherence to the IRB approved study protocol
    • accurate data collection and entry
    • proper protection of participants' privacy and confidentiality
    • accurate and timely reporting of adverse events and protocol deviations
  • Assist sites with quality assurance i.e., create corrective and prevention action plan (CAPA) and note to file (NTF) documents etc.
  • Submit protocol deviations, adverse events (AE) and severe adverse events (SAE) to IRB after discussing with Director of Clinical Research.
  • Ensure receipt and filing of acknowledgments for deviations, AEs and SAEs.
  • Ability to travel to local sites for monitoring purposes if need arises
Qualifications:
  • Bachelor's degree in Clinical Health Science/Healthcare Administration or a related field
  • At least 2 years of Clinical Research Experience preferred
  • Current and comprehensive knowledge of GCP, the International Conference on Harmonization (ICH) and FDA regulations
  • Demonstrate good decision-making, positive judgment, attention to detail and follow through skills