The Coordinator II acts as the primary contact for the study sponsor, managing day-to-day project activities, resources, and overall clinical data and protocol management for clinical trials at HonorHealth. Essential functions include managing complex protocols involving recruitment, screening, informed consent, data collection, query resolution, and serving as a liaison with the sponsor.
Requirements summary
Required qualifications include a Bachelor's Degree in Health Science or four years of related health science experience, along with two years of progressively responsible clinical research or data management experience. Candidates must possess Basic Life Support (BLS) certification and knowledge of ICH/GCP and FDA regulations is preferred.
bachelor degreeProject ManagementTrainingData CollectionLiaisonInformed ConsentGood Clinical PracticesCase Report FormsProtocol ManagementQuery ResolutionQuality Control MonitoringStudy StartupClinical Data ManagementSource Document ReviewSAE ReconciliationIRB ReportingStudy Close Out
Job description
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 II is the primary contact with the study sponsor and is responsible for the day-to-day management of project activities and resources and overall clinical data and protocol management for the conduct of clinical trials at HonorHealth.
Essential Functions Responsible for clinical and/or data management of complex protocols.
May be involved in many of the following activities: recruitment, screening, obtaining informed consent, reviewing source documents, data collection, data entry, query resolution, triggering financial payments, study startup/close out.
Serves as a liaison with sponsor.
Collects, verifies, organizes, completes and records clinical information and data in case report forms.
May be involved in many of the data related activities: CRF tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation, resolve queries and safety coding.
Assists with subject follow-up for clinical protocols and documents/report clinical study progress as required.
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 maintenance.
May participate in site initiation, interim monitoring, and study close out visits with sponsor and FDA initiated audits as needed.
May be required to handle and label samples and ship samples according to protocol requirements.
Facilitates ongoing set up and closing of clinical protocols.
Assists with creation and implementation of tools to continuously monitor team performance.
Communicates departments measurable improvements and positive trends to management.
Assists with team guideline adherence to timely preparation of study documents, data entry, and data locks.
Precepting and training on new systems and programs applicable to the coordination role.
Assists with weekly tracking and reporting of team’s workload and progress.
Assists in development and implementation of departmental operating procedures.
Represents coordination team in a variety of meetings.
May assist in the creation of business development proposals by supplying coordination related information and costs.
Assists leadership with conduct of monthly quality check of recorded and submitted data.
This includes the verification of proper documentation of the data, deviations, and compliance with deadlines.
Assists with the identification and documentation of regulatory and protocol deviation findings, including IRB reporting.
Provides assistance as needed to peer to ensure that study deadlines are met.
Identifies data management project issues and alerts leadership and makes recommendations.
Maintains communication with supervisor regarding regulatory and safety issues as well as any concerns that reflect upon Good Clinical Practices.
Participates in precepting and training of staff on data management procedures, and systems.
Performs other related duties as assigned.
Education Bachelor's Degree in Health Science or 4 years of health science-related experience - Required Experience 2 years of progressively responsible clinical/clinical research or data management experience - Required Other Experience in pharmaceutical sponsored and investigator initiated clinical research trials in the therapeutic area. - Preferred Other Knowledgeable of ICH/GCP, FDA regulations for clinical trials and strong project management skills - Preferred Other Strong writing and computer skills, including, MS Word, Excel, Access, EDC ( electronic data capture) - Preferred Licenses and Certifications Basic Life Support (BLS) - Required Clinical Research Certification - Preferred IATA Certification - Preferred
