Regulatory Affairs Specialist I-III

University of Arkansas System • Little Rock, AR

2d • Onsite

About The Position

This posting will fill one of the three levels. Regulatory Affairs Specialists will directly ensure 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.

Requirements

• Level I: Bachelor's degree plus 3 years of general research experience, or High School, GED, or formal education equivalent plus 7 years of research experience in lieu of a bachelor’s degree
• Obtain CRS certification within 2 years of hire
• Level II: Bachelor's degree plus 3-5 years of general research experience with demonstrated experience/proficiency in one or more of the following functional areas as relevant to oncology clinical trials or High School, GED, or formal education equivalent plus 7 years of research experience in lieu of a bachelor’s degree and study planning/development, regulatory and/or financial start-up, regulatory maintenance and reporting from study activation to closeout
• Obtain CRS certification within 2 years of hire
• Level III: Bachelor’s Degree plus 5 years clinical research experience with demonstrated experience/proficiency in all of the above key functional areas (see Level II)
• Must possess RAC, CCRP, CCRC, or equivalent certification at time of hire.
• Must obtain CRS within 2 years of hire.
• Proof of legal authority to work in the United States on the first day of employment.

Nice To Haves

• Oncology experience
• Clinical Research experience

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 documents 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level