Website HonorHealth
HonorHealth
Company : HonorHealth
Overview:
Looking to be part of something more meaningful? At HonorHealth, you’ll be part of a team, creating a multi-dimensional care experience for our patients. You’ll have opportunities to make a difference. From our Ambassador Movement to our robust training and development programs, you can select where and how you want to make an impact. HonorHealth offers a diverse benefits portfolio for our full-time and part-time team members designed to help you and your family live your best lives. Visit (url removed)/benefits to learn more. Join us. Let’s go beyond expectations and transform healthcare together. HonorHealth is one of Arizona’s largest nonprofit healthcare systems, serving a population of five million people in the greater Phoenix metropolitan area. The comprehensive network encompasses six acute-care hospitals, an extensive medical group with primary, specialty and urgent care services, a cancer care network, outpatient surgery centers, clinical research, medical education, a foundation, an accountable care organization, community services and more. With nearly 17,000 team members, 3,700 affiliated providers and close to 2,000 volunteers dedicated to providing high quality care, HonorHealth strives to go beyond the expectations of a traditional healthcare system to improve the health and well-being of communities across Arizona. Learn more at (url removed).
Responsibilities:
Job Summary
Position provides clinical data support for the conduct of clinical research at HonorHealth Research Institute. The position works closely with all Research Staff to collect, store and maintain data in accordance with FDA Regulations, International Council of Harmonization, and Good Clinical Practices.
Essential Functions
Assists in the coordination and management of inpatient and outpatient studies, according to protocol and sponsor amendments. Provides data and or clinical management project support for multidisciplinary clinical research, including patient screening for study eligibility, obtaining informed consent and subject registration. Collects, verifies, organizes and records clinical information and data in case report forms. Abstracts data from necessary sources to complete all forms to the required quality. Performs the following data related activities: CRF tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation and safety coding. Assists with subject follow-up for clinical protocols. Works with the research team to track study progress and may be involved in the development of periodic status reports. May assist with the preparation of annual reports and statistical information on clinical research as required by the Institute, System. IRB, or investigators.
Assists with the creation and implementation of tools to continuously improve team’s performance. Communicates department’s measurable improvements and positive trends to management. Assists with team guideline adherence to timely preparation of study documents, data entry and data locks. Participates in tracking and reporting of workload and progress. Assists in development and implementation of departmental operation procedures. Represents coordination team in study feasibility, implementation, and close out activities. May assist in creation of business development proposals by supplying data and or patient management related information. Maintains communication flow through the term of the study.
Assists with obtaining all reports and submits data forms and materials according to protocol requirements. Identifies the achievement of key milestones such as draft or final database. Provides assistance as needed to peer to ensure that study deadlines are met. Mentoring and training on new systems and programs applicable to the coordinator role. Provides support to Research Staff in execution of pharmaceutical or investigator initiated clinical protocols within scope of role. Handles and labels samples and ships samples according to protocol requirements.
Maintains communication with the Research Staff regarding regulatory and safety issues as well as any concerns that reflect upon Good Clinical Practices. Provides input and assistance to the Research Staff in maintaining the Regulatory Binders for all ongoing research studies in accordance with FDA regulations and sponsor requirements. Maintains working relationships with external customers (e.g. professional research organizations and physicians).
Assists leadership with conduct of monthly quality check of data recorded and submitted. This may include verification of proper documents of clinical data, deviations within a specific time period. Assists with identification and documentation of regulatory and protocol deviation findings. Analyzes findings and communicated possible solutions to leadership. May be involved in verification of proper reporting of events, including IRB reporting. Performs other related duties as assigned.
Education
Bachelor’s Degree – Preferred
High School Diploma or GED – Required
Experience
2 years experience working with data, or a technician working in a healthcare environment, or currently enrolled in/completed a research educational program or 1 year of experience as a clinical research admin support specialist at HonorHealth Research Institute – Required
Other Healthcare related field – Preferred
Other Strong writing and computer skills, including MS Word, Excel, EDC (electronic data capture) – Preferred
Licenses and Certifications
Basic Life Support (BLS) – Required
IATA Certification – Preferred
Facility:
Shea Medical Center
Department:
HRI-Clinical Research Coordination
Shift:
Day
Position Type:
Full-Time