Senior Regulatory Specialist
University of Illinois Cancer Center
The University of Illinois Cancer Center is seeking candidates for a Senior Regulatory Specialist, Start-Up (Clinical Trials Office) position. This position provides study activation support for institutional investigators, research staff, and research administration. This position also serves as the liaison between the CTO, research sponsors, the UIC system, physicians and participating cooperative groups, consortiums and sub-contract sites. Serve as the main point of contact for all investigators for protocol implementation-related questions/concerns.
* Serve as the main point of contact for sponsors for all aspects of the study start-up process including processing and completion of internal and external feasibilities.
* Notify and submit all study start-up documents to the proper department to begin start-up activities (regulatory, contract, finance, clinical, data management, pharmacy)
* Ensure all start-up activities have concluded and the trial is ready for activation prior to site activation announcement
* Input all new studies into OnCore.
* Assist in the intake process for all studies and communication to various parties of all requirements needed prior to opening a study.
* Assist in communicating all training requirements and contractual/regulatory processes required for onboarding new physicians, physician groups, research staff, and clinical staff who will be participating in research.
* Track all study start-up activities and provide timely reports to management.
* Participate in meetings regarding start-up activities.
* Schedule PSV, SIV and feasibility meetings for all new studies.
* Work closely with the clinical research management team to draft/execute timely communication of all research updates and new/revised policy information/updates to appropriate research community.
* Provide assistance with clinical research recruitment planning for local and affiliate trial locations.
* Troubleshoot logistical challenges in protocol implementation and conduct and maintain FAQs (or similar tools) for participating investigators and research staff to access.
* Assist with site assessment visits and feasibility reviews.
* Performs other related duties and participates in special projects as assigned.
* Bachelorís degree in a scientific discipline required. Master’s degree in science preferred.
* Minimum of five years of related research experience; in regulatory compliance preferred.
* Experience in a clinical research setting preferred.
* Knowledge of and experience working with Federal Regulations and IRBís required.
* Experience with oncology research protocols preferred
* Certification in one of the following: SoCRA, ACRP, PRIM&R preferred and required within 2 years of hire.
* Strong communication skills; ability to communicate clearly and concisely both in written and verbal communication.
For fullest consideration apply by: 7/6/18
The University of Illinois at Chicago and the State of Illinois offer competitive wages, benefit programs and resources for employees. UIC is strongly committed to providing equitable benefit options throughout each stage of employment. Many benefits become effective on the first day of employment.
Benefits offered by UIC include health care options, wellness programs, educational opportunities, tuition assistance, vacations, holidays and other leave benefits, and University retirement plans. Detailed information on specific employee benefits may be found online at: hr.uillinois.edu/benefits/
The University of Illinois at Chicago is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans and individuals with disabilities are encouraged to apply.
The University of Illinois may conduct background checks on all job candidates upon acceptance of a contingent offer. Background checks will be performed in compliance with the Fair Credit Reporting Act.
For more information visit: jobs.uic.edu/job-board/job-details?jobID=98278