SOM KC Neurology - Neuromuscular
Neuromuscular StaffPosition Title:
Research Quality Assurance AssociateJob Family Group:
Professional StaffJob Description Summary:
This position serves as a Research Quality Assurance Associate for the Neuromuscular Research Division, providing quality assurance review and monitoring for all phases of clinical and translational research.
Duties involve conducting auditing and monitoring for human research projects and using audit results to identify opportunities to improve compliance training through collaboration with educational resources. When non-compliance is identified, this position will work collaboratively with investigators to develop a proposed corrective action plan and monitor the implementation of the plan.
The position requires an individual with exceptional communication skills to work collegially with members of the research team to ensure compliance. Duties also include assistance with maintaining regulatory binder compliance for all studies.Job Description:
This position is responsible for performing study-specific compliance and monitoring 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. Performs quality and safety reviews for research throughout the life of the study.
Duties involve conducting auditing and monitoring for human research projects and using audit results to identify opportunities to improve compliance training through collaboration with educational resources. When non-compliance is identified, this position will work collaboratively with investigators to develop a proposed corrective action plan and monitor implementation of the plan.
This position will be familiar with requirements for correctly maintaining investigator site files and will assist research staff with electronic regulator binder maintenance.
The position requires an individual with exceptional communication skills to work collegially with members of the neuromuscular research team to ensure compliance. Job Duties
- Conduct GCP-related routine, requested, and for cause audits to assure that studies are conducted in accordance with sponsor protocols, GCP, and governing regulations.
- Ensure the effectiveness of the Neuromuscular Research Division by establishing and fostering strong relationships and efficient interactions with internal investigators, UKHS, the Human Research Protection Program, KUMC Research Institute, the KUMC community, and study sponsors.
- When non-compliance is identified, work collaboratively with investigators to develop a proposed corrective and preventative action plan. Monitor implementation of the plan by the Investigator.
- Be knowledgeable, stay current, and act accordingly within the framework of regulatory guidelines provided by federal, state, and local regulatory agencies and ethical guidelines pertaining to the clinical research industry.
- Act as a quality assurance resource, evaluate problems, and provide solutions.
- Assist Neuromuscular Research Division with maintenance of regulatory binders for industry-sponsored and investigator-initiated trials.
- Adherence to organizational policies and procedures as assigned by the supervisor.
- Promote a positive work environment that is maintained through open and effective communication
- Ensure quality of deliverables for projects of assigned investigators/clients.
- Performs other duties as assigned by the Director, Neuromuscular Research Division.
- Additional duties may be assigned by the supervisor.
- Bachelor's degree in a healthcare discipline, biological sciences, business or public administration and at least 2 years of related work experience OR an equivalent combination of experience and education;
- Experience with federal regulations governing human subjects research;
- Working knowledge of basic scientific methods, biological principles and medical terminology;
- High-level of organizational and analytical skills and demonstrated ability to work collegially in a complex process-oriented environment;
- Proficiency in computer software, systems and programs;
- Excellent written and verbal communication skills;
- Ability to manage multiple tasks and set priorities and meet deadlines;
- Familiarity with clinical management database systems utilizing tables, queries, etc.;
- Periodic travel to attend national meetings, host external audits, perform external monitoring, etc.
- Prior experience in quality assurance or quality control related to human research;
- Prior research administration in an academic setting;
- Experience with FDA inspections;
- Experience in developing standard operating procedures.
- Experience with Complion eRegulatory Binder System
Full timeRate Type:
$54,000.00 - $80,000.00 Minimum