Regulatory Affairs Specialist I-III (Springdale, AR)
Regulatory Affairs Specialist I-III (Springdale, AR)
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1 Vacancy
Job Description
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Closing Date:
Type of Position:
Job Type:
Regular
Work Shift:
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 $50000
- 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 theApply 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 any category or status protected by law including age race color national origin disability religion protected veteran status military service genetic information sex sexual orientation or pregnancy. Questions or concerns about the application of Title IX which prohibits discrimination on the basis of sex may be sent to the Universitys 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 .
Department:
CI Regulatory Team
Departments Website:
Summary of Job Duties:
Join the Winthrop P. Rockefeller Cancer Institute (WPRCI) in collaboration with Highlands Oncology Group (HOG) to advance groundbreaking cancer research. We are seeking a skilled Regulatory Affairs Specialist to ensure compliance and administrative excellence for multiple clinical trials. The Regulatory Affairs Specialist will manage regulatory compliance and administrative tasks for cooperative group and investigator-initiated cancer clinical trials. The role involves close collaboration with investigators sponsors contract research organizations and institutional oversight offices. The selected candidate will contribute to the success of the WPRCI Clinical Trials Office (CTO) and HOG partnership by ensuring adherence to federal regulations institutional policies and quality standards.
Qualifications:
Minimum Qualifications:
The Regulatory Affairs Specialist I-III is a tiered-level position with the level determined based on the selected candidates experience.
Level I:
- Bachelors Degree (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent) plus one (1) year 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 five (5) years of experience in clinical research and/or FDA Regulatory Affairs OR equivalent combination of education and experience.
- Must obtain CRS certification within two (2) years of hire.
Level II:
- Bachelors Degree (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent) plus three (3) yearsgeneral research experience with demonstrated experience/proficiency in one or more of the following functional areas as relevant to oncology clinical trials:study planning/development regulatory and/or financial start-up regulatory maintenance and reporting from study activation to closeout.
- Must obtain CRS certification within two (2) years of hire.
Level III:
- Bachelors Degree (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent) plus five (5) years clinical research experience with demonstrated experience/proficiency in one or more of the following functional areas as relevant to oncology clinical trials: study planning/development regulatory and/or financial start-up regulatory maintenance and reporting from study activation to closeout
- Must possess RAC CCRP CCRC or equivalent certification at time of hire.
- Must obtain CRS certification within two (2) years of hire.
Knowledge Skills & Abilities:
- Knowledge of federal regulations governing clinical research (e.g. CFR GCP).
- Strong organizational and project management abilities.
- Excellent written and verbal communication abilities.
- Ability to work collaboratively in a fast-paced multidisciplinary environment.
- Attention to detail and accuracy in documentation.
- Ability to manage multiple complex projects simultaneously.
Preferred Qualifications:
- Oncology experience
- Clinical Research experience
Additional Information:
Key Responsibilities:
Regulatory
- 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.
Leadership
- Advises the PI on administrative and regulatory requirements for proposed clinical studies or in preparing study proposals for submission. Monitors and facilitates the 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 the 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 HOG and 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.
Customer Service
- Interacts with and assists the public in a professional and friendly manner as needed. Demonstrates effective communication skills; communicates accurate and complete information; maintains strict confidentiality when necessary. Demonstrates positive working relationships with co-workers management team and ancillary departments; follows the Core Concepts of Patient and Family Centered Care and the Basic Code of Conduct Guidelines. Assist internal and external stakeholders as needed with exceptional customer service. Performs other related duties as directed to meet the goals and objectives of HOG WPRCI and UAMS.
Salary Information:
Required Documents to Apply:
Optional Documents:
Special Instructions to Applicants:
Please attach any relevant certifications (CRS RAC CCRP CCRC) if applicable.
Recruitment Contact Information:
Please contact for any recruiting relatedquestions.
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:
YesRequired Experience:
Unclear Seniority
Employment Type
Full-Time
