"PS Clinical Research Coord Sr."

The Division of Pediatric Neurology at the University of Utah School of Medicine has an opening for a Senior Clinical Research Coordinator. Coordinates complex clinical trial activities and plays a critical role in the conduct of multiple research studies. The Department of Pediatrics is the second largest department in the University of Utah School of Medicine and one of the largest pediatric departments in the country. We are committed to improving the lives of children through excellence in advocacy, education, research, and clinical care. For more information about the Department of Pediatrics, please visit: http://medicine.utah.edu/pediatrics/. Mutual respect and appreciation are highly valued in the department. The University of Utah offers a comprehensive benefits package including: Excellent health care coverage at affordable rates, 14.2% retirement contributions that vest immediately, Generous paid leave time, 11 paid Holidays per year, 50% tuition reduction for employee, spouse, and dependent children, Flex spending accounts, Free transit on most UTA services, Employee discounts on a variety of products and services including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel, Professional development opportunities. Additional benefits information is available at https://benefits.utah.edu/.

Responsibilities: Evaluate new protocols for feasibility. Thoroughly review study protocols and map process and data flow to predict areas of vulnerability. Identify, recommend, and implement solutions to address such vulnerabilities in specific clinical research trials and across the team's study portfolio. Work with PI to assess administration and logistics of the study protocol, review inclusion and exclusion criteria, scientific, ethical and regulatory issues; patient population, logistics, and protocol compliance. Work with the study team and the PI within the University and Primary Children's Hospital to ensure efficient study start-up. Organize pre-site selection visits and site initiation visits with study monitors and design, develop, and implement recruitment and retention plans for each study. Work in harmony with Business Development Director and start-up teams on efficiently starting up new clinical research studies. Assist in the development of standard operating procedures. Mentor and train new or junior research staff. Oversee, assess and ensure participant safety and strict protocol implementation/adherence; oversee compliance with GCP guidelines, federal regulations, institutional policies and procedures, and internal SOPs. Evaluate processes to identify obstacles to successful recruitment and retention of study participants. Recommend and implement innovative approaches to maximize enrollment and optimize subject retention. Implement procedures to prevent future events, including staff education and retraining. Prepare for and coordinate site visits made by sponsors or federal agencies during course and at the close of the study. Represent the research program at meetings, national and international research consortia. Prepare, submit and maintain IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence when assistance is needed. Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues. Assist in the development of training and staff certification materials, procedures, and requirements. Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study. Oversee and train team members across the entire spectrum of research studies to include, but not limited to: protocol requirements, schedule of visits, recruitment plan, execution of research plan, collecting adverse event information, maintaining study subject documentation. Determine subject population availability, develop recruitment, informed consents, and screening materials; help develop survey and study data collection instruments. Assist in the development of case report forms. Determine study visit and site/clinic workflows for studies/protocols.

Work Environment and Level of Frequency: Nearly Continuously: Office environment. Seldom: Infectious disease, oils. Physical Requirements and Level of Frequency: Nearly Continuously: Hearing, listening, talking. Often: Repetitive hand motion, walking, standing, sitting. Seldom: Bending, reaching overhead. The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit. The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patient's status and provide care as described in the department's policies and procedures manual.