Regulatory Affairs Specialist I

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Closing Date:

02/12/2025

Type of Position:

Professional Staff - Fiscal Affairs

Job Type:

RegularNo

Institution Name:

University of Arkansas for Medical Sciences

The University of Arkansas for Medical Sciences (UAMS) has 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.
 

UAMS offers amazing benefits and perks (available for benefits eligible positions only):

• Health: Medical, Dental and Vision plans available for qualifying staff and family
• Holiday, Vacation and Sick Leave
• Education discount for staff and dependents (undergraduate only)
• Retirement: Up to 10% matched contribution from UAMS
• Basic Life Insurance up to $50,000
• Career Training and Educational Opportunities
• Merchant Discounts
• Concierge prescription delivery on the main campus when using UAMS pharmacy

Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening.  To apply for the position, please click the Apply link/button.

The University of Arkansas is an equal opportunity institution. The University does not discriminate in its education programs or activities (including in admission and employment) on the basis of age, race, color, national origin, disability, religion, marital or parental status, protected veteran status, military service, genetic information, or sex (including pregnancy, sexual orientation, and gender identity). Federal law prohibits the University from discriminating on these bases. Questions or concerns about the application of Title IX, which prohibits discrimination on the basis of sex, may be sent to the University's Title IX Coordinator and to the U.S. Department of Education Office for Civil Rights.

Persons must have proof of legal authority to work in the United States on the first day of employment.

All application information is subject to public disclosure under the Arkansas Freedom of Information Act.
 

For general application assistance or if you have questions about a job posting, please contact Human Resources at askrecruitment@uams.edu.

Department:

COM | Internal Med Nephrology Research

Department's Website:

Summary of Job Duties:

The Regulatory Affairs Specialist (RAS) plays a crucial role in facilitating FDA applications for investigational drugs, biologics, and medical devices at UAMS. Key responsibilities include preparing, submitting, and maintaining regulatory documents for Investigational New Drugs (IND)/Investigational Device Exemption applications, ensuring compliance with Food and Drug Administration (FDA) and Institutional Review Board (IRB) requirements. The role demands strong problem-solving, critical thinking, and communication skills, along with the ability to coordinate various stakeholders to meet project deadlines effectively. Additionally, the RAS handles adverse event reporting, annual reports, and maintains communication with the FDA, applying federal regulations to research proposals while assisting in policy and procedure development related to regulatory affairs.

Qualifications:

• Bachelor's degree in life, natural, clinical sciences, regulatory sciences or related field plus one (1) year of clinical research or FDA Regulatory Affairs experience (e.g. IND/IDE, BLA/NDA/ANDA, PMA, 510(k), etc.) or

• High School diploma/GED plus five (5) years of clinical research or FDA Regulatory Affairs experience required.

Additional Information:

Responsibilities:

• Works with investigators on preparatory submission required IRB/regulatory paperwork for clinical trials and related FDA documents.

• Submits IRB applications timely and maintaining appropriate approvals.

• Assists with ongoing problem solving by evaluating issues and developing solutions.

• Acts as liaison and point-of-contact between principal investigator, other entities, and IRB.

• Promotes information sharing among research staff and investigators regarding human subject protection issues.

• Drafts human subjects protection section for grants and study protocols.

• Trains and assists new researchers and staff in the preparation of IRB submissions.

• Provides support with recruiting and enrolls subjects in clinical trials with managing adverse event reporting, handles annual reports, coordinates communication with FDA, and applies pertinent federal regulations to individual research proposals.

• Identifies subjects for enrollment and performing the consent process. 

• Assists with the development or revision of consent forms.

• Provides and/or obtain requested information regarding human subjects research regulation

• Maintains study logs and research data sources.

• Responsible for researching petty cash reconciliation monthly.

• Collects and maintains data from clinical trials and keeps organized records of data that has been collected.

• Checks research binders for compliance with IRB requirements and agreement with written protocols, disseminates new information or changes related to IRB requirements, develops and/or updates tools to facilitate IRB submissions.

• Drafts responses to RCO audits and IRB contingencies.

• Performs other duties as assigned.

Salary Information:

Commensurate with education and experience

Required Documents to Apply:

Resume

Special Instructions to Applicants:

Please contact askrecruitment@uams.edu for any recruiting related questions.

All application materials must be uploaded to the University of Arkansas System Career Site https://uasys.wd5.myworkdayjobs.com/UASYS  

Please do not send to listed recruitment contact.

Pre-employment Screening Requirements:

No Background Check Required

This position is subject to pre-employment screening (criminal background, drug testing, and/or education verification). A criminal conviction or arrest pending adjudication alone shall not disqualify an applicant except as provided by law. Any criminal history will be evaluated in relationship to job responsibilities and business necessity.  The information obtained in these reports will be used in a confidential, non-discriminatory manner consistent with state and federal law. 

Constant Physical Activity:

Feeling, Grasping, Hearing, Kneeling, Lifting, Manipulate items with fingers, including keyboarding, Pulling, Pushing, Reaching, Repetitive Motion, Sitting, Standing, Stooping, Talking, Walking

Frequent Physical Activity:

Balancing, Crawling, Feeling, Grasping, Hearing, Kneeling, Lifting, Manipulate items with fingers, including keyboarding, Pulling, Pushing, Reaching, Repetitive Motion, Sitting, Standing, Stooping, Talking, Walking

Occasional Physical Activity:

Crawling, Stooping

Benefits Eligible:

Yes