USC's Keck School of Medicine, Department of Medicine, is seeking a Clinical Research Regulatory Administrator to join its team. The Clinical Research Regulatory Administrator is part of the Medicine Research Unit (MRU) and is responsible for providing regulatory affairs support to the Medicine Research Unit.
The Clinical Research Regulatory Administratorworks closely with the Clinical Research Program Director and supports principal investigators. The candidate’s duties include:
Leads high-quality compliance review and coordinates all work to shepherd protocols and open studies in a timely manner
Removes obstacles from study activation, influencing timely IRB submission
Liaises with sponsors and agencies to ensure compliance with all applicable local, state, and federal regulations, statutes, and laws, resolving issues and problems, negotiating compromises, and proposing alternatives and recommendations to facilitate and expedite research
Ensures regulatory compliance for multiple clinical trials, initiating, revising and overseeing all regulatory aspects of the study start-up process
Oversees data management activities and maintenance of electronic regulatory files and binders with information pertinent to studying milestone progress
Maintains awareness of new and updated rules and regulations, alerting appropriate staff to changes, and ensure appropriate interpretation and application to new and existing studies and trial
Overall, the successful candidate will have experience working in a clinical trials research environment, have research certification, have excellent organizational skills, work well as a member of a small research team, be able to work independently, and have the ability to interact well with study staff members.Candidate will work with the PI, department, sponsor, and institution to provide assistanceinvolving regulatory affairs and IRB processes.
Preferred Education: Bachelor’s degree
Certified Clinical Research Professional (CCRP) or Certified Clinical Research Associate (CCRA)Combined experience/education as substitute for minimum education
Preferred Experience:5 years in clinical research
Preferred Field of Expertise:Extensive experience in compliance oversight, coordination, monitoring and/or auditing of clinical research studies and trials. Advanced knowledge of regulations governing human research. Familiarity with intellectual property rights, inventions, patents, and technologies. Exemplary communication and interpersonal skills, with the ability to present the business side of technical topics to non-technical audiences, and persuasively and effectively interact with relationships with various stakeholders and diverse individuals and groups.
Posting Salary Range:DOE
Percentage of Time: 100
Fixed Term: 1 year
Minimum Education: Bachelor's degree Combined experience/education as substitute for minimum education Minimum Experience: 2 years Minimum Field of Expertise: Two years’ experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Experience with submissions to the Institutional Review Board and/or the Federal Drug Administration for Investigational Drugs and Devices (IND/IDE). Knowledgeable of Informational Conference on Harmonization-Good Clinical Practice (ICH-GCP), Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP) and FDA regulations and procedures. Ability to evaluate the risks and benefits of different solutions, and proven problem-solving and decision-making skills to uncover causes of problems. Exemplary organization skills and attention to detail. Proven ability to interpret, analyze, and apply pertinent policies, procedures, regulations, and requirements. Participates in process management activities. Ability to provide both detailed information as well as summaries to management-level individuals and groups, with experience presenting ideas and solutions in non-technical, business-friendly terms. Deft interpersonal and diplomatic skills for communicating tactfully with all levels of staff and diverse individuals and groups. Experience with office management communication software/tools (e.g. Google suite, Slack, Skype).
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