Regulatory Coordinator - Cancer Center

University of Kansas Medical Center • Kansas City, MO

3d • $26 - $39

About The Position

The Regulatory Coordinator is responsible for performing study-specific regulatory and safety reporting across multiple studies. This will be accomplished by: assuring the research is compliant with applicable federal, state or international requirements, while adhering to policies of The University of Kansas Medical Center. This position will be the assigned contact for study-start up activities including IRB/Ancillary committee submissions, and maintenances of regulatory records throughout the life of an assigned protocol. The University of Kansas Cancer Center is the region's only National Cancer Institute-designated comprehensive cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.

Requirements

• 4 years of relevant work experience. Education may be substituted for experience on a year for year basis.
• Experience with regulations governing clinical research (CFR, GCP, HIPAA).
• Experience with statutes and guidelines relevant to regulatory affairs in clinical research.
• Experience with medical terminology and concepts.
• Experience working with multidisciplinary teams.
• Resume/CV
• Cover Letter

Nice To Haves

• Bachelor’s degree in relevant field of study.
• Research certification such as: Certified Clinical Research Coordinator (CCRC) or certification eligible; Certified Clinical Research Professional (CCRP) or certification eligible; Collaborative Institutional Training Initiative (CITI) training certification or other research certification eligible.
• Computer skills.
• Interpersonal skills.
• Multitasking skills.
• Communication skills.
• Analytical and problem-solving skills.

Responsibilities

• Prepare development and make submission of all regulatory documents including submission of study documents to the Institutional Review Board, collaborating with team members to ensure regulatory documents are completed and accurate.
• Maintain trial master file and/or regulatory binder.
• Provide assistance to study monitors during routine monitor visits or audits.
• Maintain regulatory records throughout the life of the trial to include: submission of all study documents to the Institutional Review Board, collaborating with team members to ensure regulatory documents are completed and accurate.
• Update protocol-specific systems with complete and accurate protocol and study information.
• Work closely with investigators, study personnel, and sponsors on relevant regulatory and/or safety concerns.

Benefits

• Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan.
• Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available.
• Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays.
• One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment.
• A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available.

What This Job Offers

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