PS Clinical Research Coord Sr.

PS Clinical Research Coord Sr. Job Summary Job Summary The Division of Pediatric Cardiology at the University Of Utah School Of Medicine has an immediate opening for a Senior Clinical Research Coordinator to provide support to Principal Investigators within the Heart Center. This successful candidate will assist in facilitating the conduct of clinical research by performing research and clinical duties, providing protocol-driven patient care for complex clinical trial activities in compliance with guidelines set by governing agencies. Actual skills and responsibilities will vary according to the specific research project. Additionally, the successful candidate for this position will be 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. The person in this position will work with Heart Center Principal Investigators to conduct studies as assigned. Specific responsibilities include participation in protocol development, creating and piloting data collection forms, identification of potential subjects, interfacing with patients and families, obtaining informed consents, scheduling study visits and tests, supervising data collection, entering study data in databases, maintaining all regulatory documents, securing and ensuring proper handling of study samples, and distributing and maintaining documentation of patient incentives. Coordinators will use medical knowledge and clinical experience to perform multiple functions for this position, including but not limited to analyzing or evaluating clinical data, developing and implementing clinical workflows for studies/protocols, performing medical reviews, and training research coordinators throughout the network. The Research Senior Coordinator will have the opportunity to participate in the dissemination of results through abstract and manuscript production as appropriate. 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 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. Assists in development of study budgets; monitors budget expenses for allied services; maintains all billing, incentive, and reimbursement records. Disseminates information about the protocol 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. Analyze study monitoring and operational reports to monitor production and data collection events; evaluate progress towards meeting required timelines and data collection tasks. Works with the Data Coordinating Center to monitor participant progression throughout study and conducts evaluation at pre-specified intervals and at end of study. Creates and maintains 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. Implement procedures to prevent future events, including staff education and retraining 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 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 shipped per study protocol and results are reported to the proper entities. Coordinates with 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. Represent the research program at meetings, national and international research consortia as determined by the Principal Investigator and Pediatric Heart Center Administrative Research Director. Organizes the activities within the assigned grant proposals under the direction of the Principal Investigator. Plays a central role in assuring participant safety, ongoing maintenance of informed consent, integrity of protocol implementation accuracy of data collection, data recording and follow up. Provides care received to research participants driven by study requirements and the collection of research data as well as clinical indications. Study procedures may include administration of investigational drugs and monitoring of side effects, performance of an experimental or investigational surgical or radiological procedure, detailed clinical assessment, for example. Comments 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 requiredNearly Continuously: Hearing, listening, talking.Often: Repetitive hand motion (such as typing), 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. Disclaimer This 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. Minimum Qualifications Bachelor's degree in a health science or related field or equivalency (one year of education can be substituted for two years of related work experience); plus, 4 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. Care is appropriate to the population served Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description. Preferences Preferences Registered nurse with research experience will be considered. 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. Excellent interpersonal and communications skills, both oral and written. Proficiency in Microsoft Office, excel 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: PRN40305B Full Time or Part Time? Full Time Work Schedule Summary: Monday through Friday, 8:00 a.m. to 5:00 p.m. Occasionally requires alternative hours during evenings, weekends and holidays as needed. Department: 00848 - Pediatric Administration Location: Campus Pay Rate Range: $47,600 to $84,249 Close Date: 2/12/2025 Open Until Filled: To apply, visit https://utah.peopleadmin.com/postings/173858 jeid-2b85387baaa2994f83ce36cfc6275946