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Form of workResearch Regulatory Affairs Sr. Manager
Work Hours/Shift:- Full Time, Days
The Sr. Manager Research Regulatory Affairs is responsible for onboarding new markets in coordination with the Site Support Manager and is knowledgeable in all areas of Research Regulatory requirements and the multiple different regulatory bodies governing research. The Sr. Manager Research Regulatory Affairs has primary responsibility for the Centralized Research Regulatory team, Research Education & Training team, clinical trial internal monitoring and Research Conflicts of Interest (COI) program, Protocol Review Monitoring System (PRMS) processes and Regulatory Support Services.
What You Will Need: KNOWLEDGE AND SKILLS REQUIRED:A thorough knowledge and understanding of the federal oversight agencies, and other bodies, governing research and their applicable federal regulations or standards, including, but not limited to, the Office of Human Research Protection (OHRP), International Conference on Harmonization (ICH), Food and Drug Administration (FDA), Office or Research Integrity (ORI), National Institutes of Health (NIH), Office of Inspector General (OIG), Office of Management and Budget (OMB), HIPAA Privacy Rules and Regulations as they relate to research, local Institutional Review Board (IRB), Central IRBs, and local research administration review and approval processes.
Detail oriented and possesses critical thinking and analytical skills necessary for problem-solving and conducting or directing thorough, accurate, and effective monitoring activities.
EDUCATION AND EXPERIENCE REQUIRED:Bachelor's degree in healthcare, Science, Nursing, Administration, or a research-related field.
At least five years' experience in Research Regulatory field, working with U.S. Federal research regulations, ICH GCP guidelines, and IRBs in a clinical research setting.
Minimum of seven years research experience in a hospital or university.
Experience with Investigator Initiated Studies (IIS)
Minimum of four years experience in a comparable management position.
Minimum of two years of experience in assisting with writing policies, procedures, guidance documents, and/or standard operating procedures in research.
Minimum of three years experience in managing direct reports.
Experience in developing educational presentations and public speaking.
EDUCATION AND EXPERIENCE PREFERRED:
Master's degree in related field, including Healthcare Administration (MHA), Nursing (MSN), Jurisprudence in Health Law (MJ), Research Administration (MRA), or Juris Doctor (JD)
Minimum of seven years of previous experience in Research Regulatory field
Five or more years of management experience.
Experience in participating in an FDA audit.
LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:
Certification through any professional research organization such as the Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Society of Research Administrators International (SRA), or Public Responsibility in Medicine & Research (PRIM&R).
