Regulatory Affairs Specialist I-III

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Closing Date : 12 / 15 / 2024

12 / 15 / 2024

Type of Position : Job Type :

Job Type : Regular

Regular

Work Shift :

Day Shift (United States of America)

Sponsorship Available :

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, affirmative action 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.

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For general application assistance or if you have questions about a job posting, please contact Human Resources at [email protected].

Department : CI Regulatory Team

CI Regulatory Team

Department's Website :

Summary of Job Duties :

This posting will fill multiple positions.

Regulatory Affairs Specialists will be directly involved in ensuring regulatory compliance and administrative management for multiple clinical trials, working closely with investigators, industry sponsors, contract research organization representatives, and UAMS institutional oversight offices.

Work load will primarily consist of industry-sponsored, cooperative group and investigator-initiated cancer clinical trials.

Position must be able to organize complex projects, provide attention to detail, and communicate effectively. Will apply knowledge of local policies and federal regulations and guidelines in support of an assigned clinical trial portfolio and the objectives of the CTO.

Contributes information and ideas related to areas of responsibility as part of a cross functional team. Ensures effective and efficient workflow and adherence to quality standards for staff / program and self.

Position maintains a working knowledge of the Code of Federal Regulations and the code of conduct for human research. The employee will work directly with pharmaceutical company sponsors, institutional investigators, and research staff.

Qualifications :

Minimum Qualifications :

Level I : Bachelor's Degree (Life / Natural / Clinical Sciences / Regulatory Sciences or equivalent) plus 1 years of experience in clinical research and / or FDA Regulatory Affairs (e.

g. IND / IDE, BLA / NDA / ANDA, PMA, 510(k), etc.) related OR High School plus 5 years of experience in clinical research and / or FDA Regulatory Affairs OR equivalent combination of education and experience.

Level II : Bachelor's Degree (Life / Natural / Clinical Sciences / Regulatory Sciences or equivalent) plus 3 years of experience in clinical research related to FDA Regulatory Affairs (e.

g. IND / IDE, BLA / NDA / ANDA, PMA, 510(k), etc.) OR High School plus 7 years of experience in clinical research related to FDA Regulatory Affairs OR equivalent combination of education and experience.

Level III : Bachelor's Degree (Life / Natural / Clinical Sciences / Regulatory Sciences or equivalent) plus 5 years of experience in clinical research related to FDA Regulatory Affairs (e.

g. IND / IDE, BLA / NDA / ANDA, PMA, 510(k), etc.) OR High School plus 9 years of experience in clinical research related to FDA Regulatory Affairs OR equivalent combination of education and experience.

Preferred Qualifications :

• Oncology experience
• Clinical Research experience

Additional Information :

Responsibilities :

• Advises the PI on administrative and regulatory requirements for proposed clinical studies or in preparing study proposals for submission.
• Monitors and facilitates study / proposal process through the review and approval process in compliance with applicable policies and procedures.
• Coordinates with NCI CIRB (NCI Central IRB) as required for all cooperative group protocol approvals in addition to local requirements.
• Participates in the development of electronic infrastructure and clinical trial management suite.
• Maintains related documentation including protocol amendments, revisions, memos, consent form changes, investigator brochures, advertisements, and study closures.
• Generates consent forms in compliance with UAMS legal, Institutional Review Board (IRB), and federal requirements.
• Prepares high-quality written documents; analyzes data, and formulates conclusions.
• Level III Regulatory Specialists may act as a team leader for special projects or during interim periods in the absence of the Regulatory Team Manager.
• Assists departmental faculty / PI in the development, preparation, and submission of research protocols and related documentation to the various campus oversight committees including IRB, PRMC, biosafety / radiation safety committees, with the intent of obtaining and maintaining approval status.
• Ensures strict adherence to the processing of all adverse event and death reports in the timeline required by the study sponsor and IRB.
• Confers with PI and support staff to secure necessary documents for proposals.
• Schedules Site Initiation and Monitoring Visits as required per protocol.
• Reviews proposals for consistency with sponsor guidelines on format, font size and page limits excluding narrative content (obtain and review sponsor guidelines).
• Monitors protocol status and advises PI on requirements and deadlines.
• Creates and manages regulatory study binders and maintains all regulatory documents.
• May perform other duties as assigned.

Physical Requirements :

Constant Physical Activity :

Hear, Read, Concentrate, Think Analytically

Frequent Physical Activity :

Hearing, Sitting, Talking

Occasional Physical Activity :

Standing, Walking

Lift / Carry Weight : 10 Lbs.

Push / Pull Weight : 10 Lbs.

Physical Environment : Inside medical Facility

Noise Level : Moderate

Visual Requirements : Color discrimination, Depth perception, Far visual acuity

Near visual acuity

Hazards : N / A

N / A

Salary Information :

Commensurate with education and experience

Required Documents to Apply :

List of three Professional References (name, email, business title), Resume

Optional Documents :

License or Certificate (see special instructions for submission instructions)

Special Instructions to Applicants :

Recruitment Contact Information :

Please contact [email protected] for any recruiting related questions.

All application materials must be uploaded to the University of Arkansas System Career Site

Please do not send to listed recruitment contact.

Pre-employment Screening Requirements :

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 :

Frequent Physical Activity :

Occasional Physical Activity :

Benefits Eligible :