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.
Internal Number: 2018-14148
Let’s transform healthcare together.
Every day, we bring patients convenient, coordinated access to healthcare while providing meaningful service to our community.
Join us and you will:
Develop professionally and achieve your career goals
Enrich your life with a focus on wellness
Enjoy a compassionate, caring culture with outreach to our local communities
Support the well-being of you and your family with a diverse portfolio of benefits
Welcome to HonorHealth.
We are a non-profit, local healthcare organization known for community service and outstanding medical quality. Our organization encompasses five acute care hospitals with approximately 10,500 employees and 3,100 volunteers, urgent care centers, clinical research, medical education, an inpatient rehabilitation hospital, an Accountable Care Organization, two foundations, and extensive community services.