Regulatory Affairs Specialist - Office Clinical & Translational Research

Regulatory Affairs Specialist – Office for Clinical & Translational Research

Join to apply for the Regulatory Affairs Specialist – Office for Clinical & Translational Research role at Cincinnati Children’s.

• Protocol – Apply a comprehensive understanding of research regulations, ethics and guidelines; analyze protocol submissions to determine compliance; oversee review and correspondence; prepare, review and submit amendments, SAE reports and continuing reviews; assist in development of protocol documents.
• Compliance – Pre‑review draft documents, advise investigators on ethical, regulatory or editorial issues; coordinate additional review requirements; maintain confidentiality and review timeliness, accuracy, availability and security.
• Process – Work audit‑ready; participate in audits, surveys, quality reviews and inspections; recommend improvements; prepare and distribute materials; compose memos, reports and training materials; develop written guidelines and educational programs.
• Procedure – Serve as a resource for faculty and staff regarding regulations during protocol review; maintain currency through training and literature; implement knowledge into the department.
• Documentation – Document regulatory activities in an electronic system; maintain written and electronic records; submit data to collaborators accurately and timely.

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

Burnet Campus

Full time

Day (United States of America)

Clinical Research Services

Regular

40

Annualized pay may vary based on FTE status $56,846.40 – $72,488.00

• Medical coverage starting day one.
• Competitive retirement plans.
• Tuition reimbursement for continuing education.
• Employee discount programs through community partners.
• Shift Differential, Weekend Differential, and Weekend Option Pay programs for qualified positions.
• Support through Employee Resource Groups.
• Physical and mental health wellness programs.
• Relocation assistance available for qualified positions.
• Benefits may vary based on FTE status and position type.

At Cincinnati Children’s, we strive to make children’s health better by combining patient care with scientific discovery. For more information on the comprehensive job description and equal opportunity statement, please refer to our website.

Cincinnati Children’s is proud to be an Equal Opportunity Employer committed to creating an environment of dignity and respect for all employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/Veteran/Disability.