Regulatory Affairs Specialist

3 weeks ago

Little Rock, Arkansas, United States University of Arkansas Full time

At the University of Arkansas, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for ensuring regulatory compliance and administrative management for multiple clinical trials. The successful candidate will work closely with investigators, industry sponsors, contract research organization representatives, and UAMS institutional oversight offices.

The ideal candidate will have a strong understanding of local policies and federal regulations and guidelines. They will be able to organize complex projects, provide attention to detail, and communicate effectively. The Regulatory Affairs Specialist will be responsible for applying knowledge of regulatory requirements to support an assigned clinical trial portfolio and the objectives of the CTO.

The successful candidate will work directly with pharmaceutical company sponsors, institutional investigators, and research staff. They will ensure effective and efficient workflow and adherence to quality standards for staff/program and self.

The University of Arkansas offers a unique combination of education, research, and clinical programs that encourages and supports teamwork and diversity. We champion being a collaborative health care organization, focused on improving patient care and the lives of Arkansans.

Benefits of working at the University of Arkansas include medical, dental, and vision plans, holiday, vacation, and sick leave, education discount for staff and dependents, and up to 10% matched contribution from UAMS. The University of Arkansas is an equal opportunity, affirmative action institution.

Responsibilities of the Regulatory Affairs Specialist include advising the PI on administrative and regulatory requirements for proposed clinical studies or in preparing study proposals for submission. They will monitor and facilitate study/proposal process through the review and approval process in compliance with applicable policies and procedures.

The successful candidate will also be responsible for coordinating with NCI CIRB as required for all cooperative group protocol approvals in addition to local requirements. They will generate consent forms in compliance with UAMS legal, Institutional Review Board (IRB), and federal requirements.

Additional responsibilities include preparing high-quality written documents, analyzing data, and formulating conclusions. The Regulatory Affairs Specialist may act as a team leader for special projects or during interim periods in the absence of the Regulatory Team Manager.

Requirements for the Regulatory Affairs Specialist include a Bachelor's Degree in Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent, plus 1 year of experience in clinical research and/or FDA Regulatory Affairs. The ideal candidate will have a strong understanding of regulatory requirements and be able to apply knowledge of local policies and federal regulations and guidelines.

The University of Arkansas is an equal opportunity employer and welcomes applications from diverse candidates. The successful candidate will be required to provide proof of legal authority to work in the United States on the first day of employment.

For general application assistance or if you have questions about a job posting, please contact Human Resources at

Department:
CI | Regulatory Team

Department's Website:

For more information about the University of Arkansas and the Regulatory Affairs Specialist role, please visit our website.

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