Clinical Research Coordinator III - Division of Nephrology
Outstanding UA benefits include health, dental, and vision insurance plans; life insurance and disability programs; paid vacation, sick leave, and holidays; UA/ASU/NAU tuition reduction for the employee and qualified family members; state and optional retirement plans; access to UA recreation and cultural activities; and more!
As a cost-saving measure related to the impact of COVID-19, Furlough and Furlough-Based Salary Programs have been approved by the Arizona Board of Regents. All new hires subject to the programs will be notified in accordance with adopted Furlough and Furlough-Based Salary Programs guidelines and will be required to comply with all measures. To learn more about the programs and whether this position is affected, please visit hr.arizona.edu/FY-2020-2021-Furlough-Program.Duties & Responsibilities
The primary job dutiesare related to all research activities in the Division of Nephrology. Thisposition will implement, maintain, document, and manage clinical trials. Inaddition, it will provide for the safety of patients involved in clinicaltrials ensuring protocol adherence. The candidate will oversee and participatein the coordination and conduct of complex clinical research and observationalstudies. These studies will include high risk, high acuity and investigationalnew drug trials, many of which are multi-site. In addition, the individual willbe accountable for high standards of clinical research practice and assist inthe development of accountability in others.
Conduct/ ClinicalResearch Practice:
- Serve as a resource for others for all aspects of conducting a clinical trialfor complex and multi-center trials.
- Collaborate on multiple projects or studies and support other staff or theworkflow involved in research work.
- Assign trials and other duties to junior staff.
- Order and maintain supplies and make day-to-day decisions in support of thestudy.
- Conducts study visits with study subjects; ensures proper collection,processing, and handling of specimens.
Regulatory Complianceand Documentation:
- Provide oversight for the preparation, review, submission and maintenance ofregulatory/contract/budget activities/submissions, ensure accuracy andtimeliness to all collaborative parties
- Coordinate and participate in monitor visits, audits, and quality reviews(internal and external) in a professional manner.
- Organize the review, correspondence and approval of human research protocolswith all regulatory authorities, including study closeout.
- Proactively take initiative to ensure recruitment stays on track with theproject timelines.
- Determine best method/s to identify potential participants for researchprotocol (advertisements, chart reviews, monitoring of clinic schedule, etc)and prepare accordingly.
- Oversee data entry and validation to ensure accuracy, quality and compliance ofdata collection process.
- Ensure quality of data submitted from study sites and assure timely submissionof data.
- Compose clear, precise and detailed correspondence.
- Develop a rapport with study participants.
- Serve as liaison to internal departments, clinical teams, regulatory agencies,physician's offices, city clinics, government agencies, academic centers, andother organizations.
- Train new staff in preparation and conduct of clinical trials.
- Assist other members by educating, providing resources and consulting ondifficult protocols or projects.
- Provides team coordination, communication, training, and quality control.Develops standard operating procedures, compliance forms, and trackingdocuments.
Knowledge, Skills, andAbilities:
- Extensive knowledge ofthe principles and techniques of the subject discipline.
- Complete knowledge ofall job functions and the broad industry best practices, techniques andstandards.
- Knowledge of modernresearch methods, data collection and analysis and skill in their application.
- Skill in leading,coordinating and/or supervising the work of others.
- Ability to workindependently except for new projects or concepts, work is reviewed to ensureobjectives were met.
- Bachelor's degree orequivalent advanced learning attained through professional level experiencerequired.
- Minimum of 5 years ofrelevant work experience