Regulatory Affairs Specialist at Cincinnati Children’s Cancer & Blood Diseases Institute | Apply Now
A rare chance has emerged for qualified candidates to join Cincinnati Children’s Cancer & Blood Diseases Institute as a Regulatory Affairs Specialist. This full-time position is based at the Burnet Campus in Cincinnati, OH, and requires a Bachelor’s degree along with over two years of relevant experience.
- Position: Regulatory Affairs Specialist – Cancer & Blood Diseases Institute
- Location: Burnet Campus, Cincinnati, OH, United States
- Department: Hematology
- Expected Starting Pay Range: $56,846.40 – $72,488.00
About The Institute
Cincinnati Children’s is a renowned pediatric hospital recognized for its commitment to improving children’s health. With a focus on a holistic approach to patient care and scientific advancement, the institution has been consistently ranked among the top children’s hospitals in the nation. The organization is dedicated to fostering innovation and collaboration among its teams to enhance patient outcomes and drive research initiatives.
Regulatory Affairs Specialist Job Description
They will apply a comprehensive understanding of research regulations, ethics, and guidelines to ensure compliance with federal, state, and institutional regulations. Responsibilities include analyzing research protocol submissions, overseeing correspondence of research protocols, and acting as a liaison between IRB members and researchers. The position involves conducting pre-reviews of draft documents, maintaining documentation for regulatory activities, and participating in audits and quality reviews.
Regulatory Affairs Specialist Responsibilities
- Analyze research protocols to determine compliance with regulations.
- Oversee the review and correspondence of research protocols.
- Prepare, review, and submit protocol amendments and continuing reviews.
- Conduct pre-reviews of draft documents and advise on ethical and regulatory issues.
- Maintain written and electronic systems to support clinical research activities.
- Participate in audits, surveys, and quality reviews.
- Compose clear and precise memos, reports, and training materials.
- Act as a resource for faculty and staff regarding regulatory issues.
Eligibility Criteria
- Bachelor’s degree in a related field.
- 2+ years of work experience in a related job discipline.
Required Skills
- Comprehensive understanding of research regulations and ethics.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Proficiency in documentation and electronic regulatory systems.
This Specialist position at Cincinnati Children’s Cancer & Blood Diseases Institute presents a significant opportunity for qualified candidates to contribute to impactful research and patient care. Interested individuals are encouraged to apply before the deadline to secure their chance to be part of this esteemed institution.
