Job Summary
The Senior Research Regulatory Specialist is responsible for overseeing the entire lifecycle of regulatory submissions related to intricate clinical trial portfolios, ensuring that all institutional compliance standards are met. This role also involves acting as a subject matter expert, working closely with investigators and various stakeholders to expedite study activation and maintain readiness for audits.
Responsibilities
- Manage comprehensive regulatory submissions for complex clinical trial portfolios.
- Ensure adherence to institutional compliance throughout the research process.
- Act as a subject matter expert in regulatory affairs and clinical research.
- Collaborate with investigators and stakeholders to facilitate timely study activation.
- Prepare for audits and ensure that the necessary documentation is in order.
Qualifications
- Bachelor’s degree or equivalent experience in clinical research (4 years minimum).
- A minimum of 4 to 7 years of dedicated experience in clinical research regulatory affairs.
- Proficiency in Clinical Trial Management Systems (CTMS) and electronic regulatory systems.
- Strong understanding of oncology clinical trials is essential.
Nicklaus Children's Hospital provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
