Regulatory Coordinator-Research

The Regulatory Coordinator is responsible for overseeing the day-to-day regulatory management of all types of clinical research protocols. The position will manage all aspects of study start-up, modification submissions, continuous reporting, and study close-out to the Institutional Review Board (IRB) and any relevant regulatory agencies including, the Institutional Biosafety Committee, the institutional Radiation Safety Committee, and the clinical trial sponsor, funding foundation, or governmental agency.

Essential Functions:

• Manage day-to-day regulatory operations and workload of regulatory team, plan resource needs and strategize growth.
• Provide regulatory support for research programs and oversee maintenance of all required regulatory documents.
• Provide regulatory start-up support for research teams for all types of clinical trials.
• Partner with study teams to provide ad hoc regulatory management for ongoing clinical trials.
• Oversee timely regulatory submissions to meet project timelines.
• Create and maintain position related Standard Operating Procedures (SOPs) and ensures procedural compliance.
• Identify program improvement opportunities and lead improvement efforts within team, including technology solutions; identify opportunities for expanding solutions to study teams.
• Coordinate with appropriate department to address regulatory-related quality and compliance matters.
• Assist with the development of standard regulatory-related training requirements and with ongoing education and training for investigators and research personnel.
• Work with Quality Assurance to perform internal audits and quality assurance reviews on regulatory files, as needed
• Write and edit clinical research protocol consent forms in accordance with federal regulations and guidelines and good clinical practice (GCP) guidelines.
• Liaise with appropriate personnel, departments and outside entities on clinical trial regulatory operations.

Qualifications:

• Bachelor's degree in Clinical Health Science or Healthcare Administration
• 2 years of Clinical Research Experience preferred
• Exhibits good communication and organizational skills
• Proficient at computer usage and Microsoft software
• Experience with electronic health record systems and clinical trial management systems preferred

As one of the nation's premier pediatric health care systems, we've made a promise to do whatever it takes to prevent and treat even the most disabling childhood conditions. It's a promise that extends beyond our nationally recognized clinical treatment to an entire integrated spectrum of research, advocacy, education, and prevention.

Equity, diversity, and inclusion guide our growth and strategy.  We are looking for individuals who are passionate about, and committed to, leading efforts to provide culturally relevant care, reducing health disparities, and helping build a diverse and inclusive environment.  All Nemours Associates are expected to ensure that these philosophies are embedded in their day-to-day work with colleagues, patients and families.  

Nemours aspires to have its workforce and providers reflect the rich diversity of the communities we serve.  Candidates of diverse backgrounds, race and ethnicity, religion, age, gender, sexual orientation, and those committed to working with diverse populations and conversant in multicultural values are strongly encouraged to apply. Please click here to review Nemours Anti-Racism Statement (nemours.org). 

 

To learn more about Nemours and our commitment to treat every child as if they were our own, visit us at www.nemours.org.