Regulatory Affairs Specialist - Office Clinical & Translational Research

Job Responsibilities

• Protocol - Apply a comprehensive understanding of research regulations, ethics and guidelines, analyze research protocols submissions (new protocols, continuing review, changes to protocols, one-time use request and adverse events) to determine compliance with regulations. Oversee the review and correspondence of research protocols. Use independent judgment to interpret, analyze, and apply federal, state and CCHMC guidelines to promote ethical practices in research involving human subjects and to ensure compliance to those regulations by faculty and staff investigators.
  
  Work directly with individual faculty and staff investigators and research support staff to address human subjects issues during protocol review. Answer questions and problem solve for investigators, faculty, staff, research coordinators and students. Act as a liaison between IRB members and researchers to promote information flow. Prepare, review and submit all protocol amendments, SAE reports, and continuing reviews. Complete all reviews and submissions in a timely manner, meeting all deadlines.
  
  Under the guidance of senior staff, may assist in the development of protocol documents including but not limited to the protocol and consent forms.
• Compliance - Upon request from investigators, conduct pre-reviews of draft documents (such as new protocol submissions, exemptions, and changes of protocol) and advise investigators and research coordinators regarding potential ethical, regulatory, editorial or content issues before they are submitted for full IRB review. Determine which research protocols or issues have additional requirements, such as the need for review by an outside expert, and coordinate the process to meet these requirements.
  
  Follow policies and procedures governing the handling of confidential information as defined by Cincinnati Children's mission and applicable laws and regulations. Review timeliness, accuracy, availability and security of information.
• Process - Work daily in an audit ready manner. Organize and participate in activities to prepare for audits, surveys, quality reviews, and inspections. Participate in improving organizational performance through recommending areas or approaches for improvement activities, performing new procedures, collecting data and providing input to department discussions. Participate in staff committee, subcommittee, or special project groups. This may include research and writing, coordinating meeting schedules, preparing and distributing materials, recording minutes to document progress, and communicating the final outcome.
  
  By applying a comprehensive understanding of research and ethics, compose clear and precise memos, reports and training materials. Assist in developing written guidelines and educational materials for investigators (faculty and staff). Contribute to planning and presenting educational programs for investigators, research coordinators, and other groups. Use creative and effective presentation skills. Participate in establishing job requirements and goals; perform duties at the desired level of competency.
• Procedure - Act as a resource for faculty and staff regarding regulations during research protocol review. Serve as an informational and referral resource for the research community regarding regulatory, ethical and procedural issues. Maintain currency in field through cross-training, continuing education, literature and seminars. Implement this knowledge into the department.
• Documentation - Document the conduct of each protocol's regulatory activities in an electronic regulatory system. Maintain written and electronic systems to support the clinical research activities. Submit data to collaborative parties accurately and within a timely manner.

• Bachelor s degree in a related field
• 2+ years of work experience in a related job discipline

• Primary
  
  Location:
  
  Burnet Campus
• Schedule:
  
  Full time
• Shift: Day (United States of America)
• Department:
  Clinical Research Services
• Employee Status:
  Regular
• FTE: 1
• Weekly
  
  Hours:
  
  40

• Expected Starting Pay Range
• Annualized pay may vary based on FTE status $56,846.40 - $72,488.00

• A…