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 honorhealth.com/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 HonorHealth.com.
Responsibilities
Job Summary
The Coordinator-Clinical Research III is an experienced coordinator who demonstrates autonomy in the management of complex protocols, precepting and mentoring of new research staff, and assisting in quality review and process improvement. This position supports our organization's efforts to achieve service excellence to our patients, investigators, and sponsors.
Essential Functions
- Responsible for the coordination management of complex protocols (multi-arm, multi-disciplinary, etc.). May be the sole coordinator on studies. May be responsible for activities such as screening, recruitment, obtaining informed consent, creation and review of source documents, data collection, data entry, query resolution, triggering financial payments, study startup/close out. May be responsible for the following: collecting, verifying, organizing, completes and records clinical information and data in case report forms, CRF tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation, query resolution and recording clinical information and data in case report forms, safety coding. Assists with subject follow-up for clinical protocols and documents/report clinical study progress to assigned study team. Obtains all reports and submits data forms and pathology and radiology materials according to protocol requirements. Conducts protocol administration quality control monitoring, enforcement and database maintenancety coding. Conducts protocol administration quality control monitoring and enforcement. May be responsible for database maintenance. Acts as the liaison with the sponsor/CRO.
- Assists with creation & implementation of tools to continuously improve team's performance. Communicates department's measurable improvements & positive trends to management. Assists with team guidelines adherence to timely preparation of study documents, data entry, and data locks.
- Precepting and training on new systems and programs applicable to study coordination for research staff, including but not limited to coordination team, research nurses, infusion nurses, program managers, and regulatory affairs personnel.
- Tracking and reporting of weekly workload & progress. Assist in development and implementation of departmental operating procedures. Represents coordination team in budget development related meetings. May assist in the creation of business development proposals by supplying coordination related information and costs. Maintains communication flow in regards to study budget agreements, and budget amendments through the term of the project Collecting, organizing, and reviewing data as well as the development of data points for IIT trials.
- Assists leadership with conduct of monthly quality checks of recorded data, verification of proper documentation, deviations, and compliance with timelines. Assists with identification & documentation of regulatory and protocol deviation findings. Analyzes findings and communicates potential solutions to management. Verification of proper reporting of events, including IRB reporting. Providing observations and feedback on IIT data at various study timepoints.
- Provides assistance to peers to ensure that study deadlines are met (data entry, query resolution, source document creation, review of study start up materials) Performs other related duties as assigned.
Education
- Bachelor's Degree in Health Science - Preferred
- Bachelor's Degree or 4 years' work related experience in Health Science - Required
Experience
- 4 years of progressively responsible clinical or data management experience - Required
- Other Experience in pharmaceutical sponsored and investigator initiated clinical research trials in the therapeutic area. - Preferred
- Other Proficiency in MS Word, outlook, PowerPoint, Excel, EDC (electronic data capture) Knowledge of ICH/GCP, FDA regulations for clinical trials Excellent written and verbal communication skills - Preferred
Licenses and Certifications
- Basic Life Support (BLS) - Required
- Clinical Research Certification - Preferred
- IATA Certification - Preferred
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