PS Clinical Research Coord

PS Clinical Research Coord Job Summary Job Summary The Department of Pediatric Cardiology at the University of Utah, School of Medicine has an immediate opening for a Clinical Research Coordinator to provide support to Principal Investigators in the Division of Pediatric Cardiology. This position is responsible for coordinating the implementation, quality control, and completion of research studies while accomplishing study objectives and for maintaining compliance with guidelines set by government agencies. Examples of responsibilities include submission of IRBs, interfacing with patients and families, obtaining informed consents, supervising data collection, and entering study data in electronic databases. 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 Essential Functions Preparation, submission and annual renewal of IRBs, including preparation of all necessary regulatory documents related to the study protocol. Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies. Monitors budget expenses and fees for internal services. Reviews charges and allocates research charges appropriately. Disseminates information about the protocol to junior research staff and auxiliary personnel. Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study-related parties. Coordinates and monitors participant progression throughout study and conducts evaluation at end of study. Creates a system to track data entry and audit for completeness, accuracy, and timeliness of data collection. Recognizes, tracks and reports adverse events and protocol deviations. Prepares for and coordinates site visits made by sponsors or federal agencies during the course of and at the close of the study. Prepares, submits and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence. Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed. Completes ongoing training on techniques of clinical research coordination and practices, FDA Good Clinical Practices (GCP), and clinical research standard operating procedures to ensure compliance with policy and procedure, research sponsors and Federal rules and regulations. Assures proper laboratory samples are collected and results are reported to the proper entities. Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis. Assists the Principal Investigator in the development of study materials and protocols. Attends all appropriate meetings as determined by the Primary Investigator and Heart Center Research Director. Organizes the activities within the assigned grant proposals under the direction of the Primary Investigator. DisclaimerThis job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. Work Environment and Level of Frequency that may be required:Nearly Continuously: Office environment.Seldom: Infectious disease, oils (there is air or skin exposure to oils or other cutting fluids). Physical Requirements and Level of Frequency that may be required:Nearly Continuously: Hearing, listening, talking.Often: Repetitive hand motion (such as typing), walking, standing, sitting.Seldom: Bending, reaching overhead. Minimum Qualifications Bachelors degree in a health sciences or related field or equivalency (one year of education can be substituted for two years of related work experience) with two years professional research experience and completion of University RATS Clinical Certification within one year of hire required. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required. Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred. Departments may require IRB CITI Course or IATA DGR training within a specified timeframe. Departments may prefer a nursing degree for this position, which requires the incumbent to have two years related experience and possess a nationally recognized research compliance certification. This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description. Preferences Department Specific Preferences Registered nurse is preferred. Prior experience in the pediatrics and/or cardiovascular clinical research areas. Credentialing as a Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or other related certification. Experience with human subjects research, demonstrated human relations skills, and working knowledge of Good Clinical Practices, FDA, HIPPA ICH, and IRB regulations and regulatory compliance. Must be a self-starter with exceptional organizational skills, ability to function independently, and attention to detail. Ability to work within a team. Excellent interpersonal and communications skills, both oral and written. Proficiency in Microsoft Office and the ability to learn new software programs. IRB CITI Course for Human Subjects and CITI GCP or IATA DGR training are required within 3 weeks of hire. Applicants will be screened according to preferences. Special Instructions Requisition Number: PRN40304B Full Time or Part Time? Full Time Work Schedule Summary: 40 hours per week; availability Monday through Friday, 8:00am – 5:00pm, with some flexibility for evenings, weekends, and holidays as needed. Department: 00848 - Pediatric Administration Location: Campus Pay Rate Range: $39,300-$68,349 Close Date: 2/11/2025 Open Until Filled: To apply, visit https://utah.peopleadmin.com/postings/173855 jeid-d5e653d4648b644682b6f578f2d67819