"Alerted.org

Work Shift:

Please see job description for details.

Time Type:

Full time

Department:

CC035772 Regulatory Clinical Research Operations

Summary:

The Supervisor, Regulatory Affairs will oversee the development and implementation of policies and procedures to ensure compliance with local and federal regulations. This role will manage a team of regulatory professionals and work closely with investigators, sponsors, and institutional review boards (IRBs) to facilitate regulatory submissions and approvals.

Additional Information:

Required Education:

Bachelors Degree or Equivalent Experience

Recommended Education:

Required Work Experience:

Related Field - 5 years of experience

Recommended Work Experience:

Required Certifications:

Recommended Certifications:

Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals, Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates

Description

+ Lead, supervise, and mentor a team of regulatory coordinators, providing strategic direction, performance feedback, and professional development opportunities. Serve as the regulatory team lead and subject matter expert for ACRI.

+ Oversee the end-to-end process for the preparation, submission, and maintenance of regulatory documents, including IRB and FDA filings (sIND, IND, IDE).

+ Ensure all clinical research projects are executed in compliance with applicable regulatory requirements (FDA, ICH-GCP, HIPAA, etc.) and internal policies

+ Act as the primary regulatory liaison between the research team and external/internal stakeholders, including sponsors, IRBs, regulatory agencies, and oversight bodies.

+ Lead the development and execution of regulatory strategies, systems, SOPs, and best practices to optimize regulatory operations and ensure audit readiness.

+ Track and interpret changes in regulatory requirements, proactively guiding the team and research staff on compliance expectations.

+ Build strong cross-functional partnerships across Clinical Operations, Research Integrity, and Corporate Compliance, ensuring alignment with broader organizational goals.

+ Represent the organization in interactions with regulatory bodies, including the UAMS IRB and the UAMS Office of Research Regulatory Affairs.

+ Serve as the process owner and subject matter expert for the eReg electronic regulatory management system, ensuring efficient and compliant document workflows.

+ Establish team goals, performance metrics, and continuous improvement plans to drive operational excellence in regulatory affairs.

+ Other duties as assigned

Arkansas Children’s (https://www.archildrens.org/about-us) is the only hospital system in the state dedicated to caring for children, which enables us to uniquely shape the landscape of pediatric care in Arkansas.

Arkansas Children’s is driven by four core values—safety, teamwork, compassion and excellence—which inform every action.

Arkansas Children’s Hospital has received Magnet Status (https://www.archildrens.org/about-us/magnet-recognition) from the American Nurses Credentialing Center (ANCC), for nursing excellence and patient outcomes. And we are nationally ranked by U.S. News & World Report (https://www.archildrens.org/about-us/awards-and-recognition) for Cancer, Cardiology & Heart Surgery, Diabetes & Endocrinology, Nephrology, Neurology & Neurosurgery, Pulmonology & Lung Surgery and Urology.

For more than a century, Arkansas Children’s has met the unique needs of children. But we’re more than just a hospital treating sick kids—our services include two hospitals, a pediatric research institute, foundation, clinics, education and outreach, all with an unyielding commitment to making children better today and healthier tomorrow.

Arkansas Children’s Little Rock campus includes a 336-bed hospital with the state’s only pediatric Level 1 Trauma Center, burn center, Level 4 neonatal intensive care and pediatric intensive care, as well as a nationally-recognized transport service. And Arkansas Children’s Northwest (https://www.archildrens.org/locations/arkansas-childrens-nw) provides inpatient and emergency care, clinic rooms and diagnostic services to children in that corner of the state.

_“Arkansas Children’s is a place of hope and comfort for children and parents. When you are at children’s, you are part of an elite team united with a common goal of saving children and making their lives better.”_ Michael – Business Operations Manager

•Arkansas Children’s Hospital is a prestigious institution that cares for children.” Linda – Information Systems Analyst

•We are an organization of care, love, and hope while we champion children.” Angela – Parking and Fleet Coordinator

•Care, love, and hope for children!” Kathy – Administrative Assistant

•When I think of my time here at Arkansas Children’s Hospital, I can honestly say that it has given me a unique perspective on the human condition, and the various roles that we all have in patient care. As a supply assistant, I have a very important job ensuring that the doctors and nurses have what they need to provide the world class medical care to the Children of Arkansas and surrounding states. Being a Champion for Children is more than a catch phrase, it is a way of life!” Nick – Supply Assistant

Arkansas Children's provides equal employment opportunity to all persons without regard to age, race, color, religion, national origin or citizenship status, disability, military status, sexual orientation, gender identity or expression, pregnancy or any other category protected by federal, state and local laws. Further, Arkansas Children's will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.