Regulatory Affairs Specialist I-III

• Oncology experience
• Clinical Research experience

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. 

• 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

• 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

• 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.  

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

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.