United States onlyNemours is seeking a Regulatory Coordinator to join our Nemours Children's Health team based in Wilmington, DE. This is a remote position.
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
Nemours Children’s Health is an internationally recognized children’s health system. With more than 1.7 million patient encounters annually, we provide medical care in five states through two freestanding state-of-the-art children’s hospitals — Nemours Children’s Hospital, Delaware and Nemours Children’s Hospital, Florida. Our pediatric network includes 80 primary-urgent-and specialty care practices and more than 40 hospitalists serving 19 affiliated hospitals. We generate annual revenues of more than $1.7 billion derived from patient services, contributions from the Alfred I. DuPont Trust, as well as other income.
As one of the nation's premier pediatric health systems, we’re on a journey to discover better ways of approaching children’s health. Putting as much focus on prevention as cures and working hand in hand with the community to make every child’s world a place to thrive. It’s a journey that extends beyond our nationally recognized clinical treatment to an entire integrated spectrum of research, advocacy, education, and prevention, leading to the healthiest generations of children ever.
Inclusion and belonging 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 an inclusive and supportive environment. All of our associates are expected to ensure that these philosophies are embedded in their day-to-day work with colleagues, patients and families.
To learn more about Nemours Children’s and how we go well beyond medicine, visit us at www.nemours.org.
