Research Regulatory Specialist - Now Hiring
BayCare
Clearwater, FL
research
regulatory
research
clinical research
regulatory
protocol
healthcare
subjects
administration
team
investigators
research projects
compliance
November 30, 2022
BayCare
Clearwater, FL
FULL_TIME, PART_TIME
Job Description
Description:
Responsible for ensuring their assigned research team members, investigators and associated portfolio of clinical research projects are in compliance with all applicable institutional, sponsor and governmental policies and laws. Acts as a liaison between the sponsor, Clinical Research Operations, Institutional Review Board and internal departments/ staff to complete initial Institutional Review Board protocol submissions, submit study amendments in a timely fashion including changes to the protocol, consent forms and other study documents, prepare for and facilitate monitoring visits, ensure study regulatory files are up to date & audit ready, maintain regulatory master files for industry & investigator initiated clinical trials, aid in the development of protocol specific standard operation procedures, and develop & train Clinical Research Coordinators on guidelines related to consent, ethical conduct and protection of human subjects. Preferred Certification includes SOCRA (Society of Clinical Research Associates), ACRP (Association of Clinical Research professionals) or CCRC (Certified Clinical Research Coordinator). Required Education and Experience includes Bachelor's Degree in in Business, Healthcare Management, Nursing or related and 2 years of research, regulatory, or other healthcare administration experience OR High School Diploma and 5 years of research regulatory experience OR Masters Degree in related field and 1 year of research, regulatory, or other healthcare administration experience. Additional Specific Skills includes extensive knowledge of FDA regulation and human subjects protection.
Qualifications:
Certifications and LicensuresPreferredReference summary for details
EducationRequiredBachelor'sReference summary for detailsOrHigh School or EquivalentReference summary for detailsOrMaster'sReference summary for details
ExperienceRequired5 yearsReference summary for detailsOr2 yearsReference summary for detailsOr1 yearReference summary for details
Specific SkillsRequiredCustomer service skillsRequiredWritten and verbal communication skillsRequiredInterpersonal skillsRequiredDelegation skillsRequiredWork independentlyRequiredWork with a teamRequiredCritical thinking skillsRequiredOrganizational skillsRequiredAdministrative and clerical skillsRequiredComputer skills appropriate to positionRequiredKnowledge of regulatory standards appropriate to positionRequiredMedical terminology use and understanding
Responsible for ensuring their assigned research team members, investigators and associated portfolio of clinical research projects are in compliance with all applicable institutional, sponsor and governmental policies and laws. Acts as a liaison between the sponsor, Clinical Research Operations, Institutional Review Board and internal departments/ staff to complete initial Institutional Review Board protocol submissions, submit study amendments in a timely fashion including changes to the protocol, consent forms and other study documents, prepare for and facilitate monitoring visits, ensure study regulatory files are up to date & audit ready, maintain regulatory master files for industry & investigator initiated clinical trials, aid in the development of protocol specific standard operation procedures, and develop & train Clinical Research Coordinators on guidelines related to consent, ethical conduct and protection of human subjects. Preferred Certification includes SOCRA (Society of Clinical Research Associates), ACRP (Association of Clinical Research professionals) or CCRC (Certified Clinical Research Coordinator). Required Education and Experience includes Bachelor's Degree in in Business, Healthcare Management, Nursing or related and 2 years of research, regulatory, or other healthcare administration experience OR High School Diploma and 5 years of research regulatory experience OR Masters Degree in related field and 1 year of research, regulatory, or other healthcare administration experience. Additional Specific Skills includes extensive knowledge of FDA regulation and human subjects protection.
Qualifications:
Certifications and LicensuresPreferredReference summary for details
EducationRequiredBachelor'sReference summary for detailsOrHigh School or EquivalentReference summary for detailsOrMaster'sReference summary for details
ExperienceRequired5 yearsReference summary for detailsOr2 yearsReference summary for detailsOr1 yearReference summary for details
Specific SkillsRequiredCustomer service skillsRequiredWritten and verbal communication skillsRequiredInterpersonal skillsRequiredDelegation skillsRequiredWork independentlyRequiredWork with a teamRequiredCritical thinking skillsRequiredOrganizational skillsRequiredAdministrative and clerical skillsRequiredComputer skills appropriate to positionRequiredKnowledge of regulatory standards appropriate to positionRequiredMedical terminology use and understanding
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