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The Ohio State University

The university is an equal opportunity employer, including veterans and disability.

Lead Regulatory Compliance Officer | CCC - Clinical Trials Office

ComplianceComplianceFull TimeRemoteLeadTeam 51-200

Location

United States

Posted

115 days ago

Salary

0

Seniority

Lead

No structured requirement data.

Job Description

Lead Regulatory Compliance Officer | CCC - Clinical Trials Office

The Ohio State University

Screen reader users may encounter difficulty with this site. For assistance with applying, please contact hr-accessibleapplication@osu.edu. If you have questions while submitting an application, please review these frequently asked questions. Current Employees and Students: If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application process. Welcome to The Ohio State University's career site. We invite you to apply to positions of interest. In order to ensure your application is complete, you must complete the following: - Ensure you have all necessary documents available when starting the application process. You can review the additional job description section on postings for documents that may be required. - Prior to submitting your application, please review and update (if necessary) the information in your candidate profile as it will transfer to your application. Job Title: Lead Regulatory Compliance Officer | CCC - Clinical Trials Office Department: CCC | Clinical Trials Office Position Summary Lead Regulatory Compliance Officer serves as primary resource in regulatory aspects by providing regulatory expertise to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the OSUCCC Clinical Trials Office. Responsibilities - Assists the Regulatory Manager with the daily oversight of the Regulatory team and monitoring of the regulatory research compliance function across all disease teams managed by the Clinical Trials Office (CTO). - Conducts interviews for regulatory staff and trains, mentors, and supervises staff. Serves as the subject matter expert for all regulatory compliance officers within the department by monitoring & ensuring compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state & industry sponsor regulations. - Answers questions and provides technical support to junior members on the team. - Provides coverage/back up as needed for Regulatory manager and/or team members. Serves as lead Regulatory contact for external audits; performs quarterly spot checks of regulatory files. - Participates in the development of SOPs and Processes for the regulatory team to stay current with the changing regulatory requirements and training. Participates in the creation and delivery of onboarding and educational training programs, tools and materials for CTO staff, and investigators. - Provides regulatory guidance, direction and support to all members of research team. - Stays current on legislation, rules, regulations, procedures, and development; educate physicians and staff regarding change as related to clinical research protocols, university staff, affiliates, and patients. - Work with CTO Managers and coordinators as needed to ensure understanding of study protocols. Job Requirements Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required; Master’s degree in a relevant field desired; clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) required. Three to five years of experience in a clinical research or administrative capacity working on clinical research projects required; knowledge of clinical research regulations and compliance issues especially related to the use of human and animal subjects required; experience and knowledge of federal & industry research sponsor requirements preferred; experience in a regulatory affairs capacity in a medical research setting desired; experience in protocol development desired. Additional Information: Research Administration / Research Compliance - Individual Contributor - Specialized - S4 Consultant Location: Remote Location Position Type: Regular Scheduled Hours: 40 Shift: First Shift Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process. Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions. The university is an equal opportunity employer, including veterans and disability.

Job Requirements

  • Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required.
  • Master’s degree in a relevant field desired.
  • Clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) required.
  • Three to five years of experience in a clinical research or administrative capacity working on clinical research projects required.
  • Knowledge of clinical research regulations and compliance issues especially related to the use of human and animal subjects required.
  • Experience and knowledge of federal & industry research sponsor requirements preferred.
  • Experience in a regulatory affairs capacity in a medical research setting desired.
  • Experience in protocol development desired.
  • Final candidates are subject to successful completion of a background check.
  • A drug screen or physical may be required during the post offer process.

Benefits

  • Remote Location
  • Regular Position Type
  • Scheduled Hours: 40
  • Shift: First Shift

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