Clinical Trial Monitor Job at 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 honorhealth.com/benefits to learn more.
Join us. Let’s go beyond expectations and transform healthcare together.
HonorHealth is a non-profit, local community healthcare system serving an area of 1.6 million people in the greater Phoenix area. The network encompasses six acute-care hospitals, an extensive medical group, outpatient surgery centers, a cancer care network, clinical research, medical education, a foundation, and community services with approximately 13,100 team members, 3,500 affiliated providers and nearly 700 volunteers. HonorHealth was formed by a merger between Scottsdale Healthcare and John C. Lincoln Health Network. HonorHealth’s mission is to improve the health and well-being of those we serve.
As a community healthcare system, we have a unique responsibility to keep our facilities as safe as possible to protect our patients and team members. With this in mind, we require all new hires to have received the first dose of a COVID-19 vaccine before their start date and be scheduled for their second dose. New hires who choose to receive the Johnson & Johnson vaccine only need one dose to fulfill this requirement. Reasonable accommodations will be considered.
Please note, while remote all work must be completed in Arizona for this role.
Responsibilities
Job Summary
The Clinical Trial Monitor participates in the design, administration, and monitoring of Investigator initiated clinical trials. Ensures compliance with Institutional Review Board approved protocols. Monitors the clinical trial and ensures that is conducted in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements. The monitor verifies the rights and well-being of human subjects are protected. The reported trial data are accurate, complete and verifiable from source documents.
Routine Monitoring – Ensures site continuing protocol and GCP compliance, safety of study subjects and, data integrity. Assist the investigational team in problem solving. Verifies source documents and other trial records are accurate, complete, and maintained in a timely manner. Verifies investigational product(s) proper storage, dispensation and administration to eligible subjects, Review of documents including instructions, receipt and disposal of investigational product. Ensures regulatory inspection readiness at assigned clinical sites. Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
Close Out – Ensures the investigation files are archived properly. Ensures all unused materials, documents, and/product is disposed of appropriately.
Pre-Trial Monitoring –Ensures site qualification, investigator and study staff are adequately trained.
Designs and develops electronic case report forms.
Ensures facility readiness, and all necessary supplies are available for the conduct of the clinical trial.
Ensures resources are available, and remain adequate throughout the clinical trial. Verifies that facilities including laboratory, equipment, and staff, are adequate to safely and properly conduct the clinical trial and remain adequate throughout the clinical trial.
Provides written communication to the Principal Investigator of trial progress, problems discovered, needs for the trial, and solicit solutions.
Auditing – Conducts routine and for cause audits of clinical trials. Develops written correspondence of audit findings. Works with the study team to develop corrective action plans.
Trial Initiation – Ensures study materials, documents, products are available. Conduct site(s) protocol training ensures the investigational team understands to protocol and Good Clinical Practice (GCP) requirements.
Qualifications
Education
Bachelor's Degree in health-related field; preferably with medical training or background. Required
Experience
2 years clinical trials monitoring experience required. Required
Facility
Shea Medical Center
Department
HHRI IRB Compliance
Work Hours
Monday-Friday 8am - 5pm flexible
Shift
01 - Days
Position Type
Regular Full-Time
Please Note :
apexdining.ca is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, apexdining.ca provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.
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 a non-profit, local community healthcare system serving an area of 1.6 million people in the greater Phoenix area. The network encompasses six acute-care hospitals, an extensive medical group, outpatient surgery centers, a cancer care network, clinical research, medical education, a foundation, and community services with approximately 13,100 team members, 3,500 affiliated providers and nearly 700 volunteers. HonorHealth was formed by a merger between Scottsdale Healthcare and John C. Lincoln Health Network. HonorHealth’s mission is to improve the health and well-being of those we serve.
As a community healthcare system, we have a unique responsibility to keep our facilities as safe as possible to protect our patients and team members. With this in mind, we require all new hires to have received the first dose of a COVID-19 vaccine before their start date and be scheduled for their second dose. New hires who choose to receive the Johnson & Johnson vaccine only need one dose to fulfill this requirement. Reasonable accommodations will be considered.
Please note, while remote all work must be completed in Arizona for this role.
Responsibilities
Job Summary
The Clinical Trial Monitor participates in the design, administration, and monitoring of Investigator initiated clinical trials. Ensures compliance with Institutional Review Board approved protocols. Monitors the clinical trial and ensures that is conducted in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements. The monitor verifies the rights and well-being of human subjects are protected. The reported trial data are accurate, complete and verifiable from source documents.
Routine Monitoring – Ensures site continuing protocol and GCP compliance, safety of study subjects and, data integrity. Assist the investigational team in problem solving. Verifies source documents and other trial records are accurate, complete, and maintained in a timely manner. Verifies investigational product(s) proper storage, dispensation and administration to eligible subjects, Review of documents including instructions, receipt and disposal of investigational product. Ensures regulatory inspection readiness at assigned clinical sites. Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
Close Out – Ensures the investigation files are archived properly. Ensures all unused materials, documents, and/product is disposed of appropriately.
Pre-Trial Monitoring –Ensures site qualification, investigator and study staff are adequately trained.
Designs and develops electronic case report forms.
Ensures facility readiness, and all necessary supplies are available for the conduct of the clinical trial.
Ensures resources are available, and remain adequate throughout the clinical trial. Verifies that facilities including laboratory, equipment, and staff, are adequate to safely and properly conduct the clinical trial and remain adequate throughout the clinical trial.
Provides written communication to the Principal Investigator of trial progress, problems discovered, needs for the trial, and solicit solutions.
Auditing – Conducts routine and for cause audits of clinical trials. Develops written correspondence of audit findings. Works with the study team to develop corrective action plans.
Trial Initiation – Ensures study materials, documents, products are available. Conduct site(s) protocol training ensures the investigational team understands to protocol and Good Clinical Practice (GCP) requirements.
Qualifications
Education
Bachelor's Degree in health-related field; preferably with medical training or background. Required
Experience
2 years clinical trials monitoring experience required. Required
Facility
Shea Medical Center
Department
HHRI IRB Compliance
Work Hours
Monday-Friday 8am - 5pm flexible
Shift
01 - Days
Position Type
Regular Full-Time
Please Note :
apexdining.ca is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, apexdining.ca provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.