As a member of the clinical affairs team and reporting to the Manager of Field Clinical Monitoring, this individual has responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. He/she ensures that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements. The Field Clinical Monitor participates in clinical research programs by assisting with the development of study protocols, case report forms, clinical reports; and interfaces with site coordinators, investigators, Clinical Research Organizations (CRO), and other company representatives.
Principal Duties and Responsibilities
- Perform site qualification, site initiation, interim monitoring, and close out visits.
- Verify that all research staff and facilities have adequate qualifications and resources, and these remain adequate throughout the trial.
- Verify that the investigator follows the approved protocol, US FDA, ICH, GCP, and applicable local requirements in the conduct of the trial.
- Conduct source document verification and source data review activities during the conduct of the trial
- Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the Investigator.
- Assist in the design of study protocol, case report forms, informed consent form for sound and thorough data collection to support the device through the approval process.
- Assist site coordinators, investigators, CRO staff (as applicable) in collecting data in a timely manner that meets the protocol and monitoring plan requirements.
- Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols.
- Assist in the training of junior field clinical monitors and other clinical staff.
- Perform other clinical duties when requested.
- A life sciences degree, which can vary from a Bachelor, Masters, or Doctorate, or a current Registered Nurse license.
- At least four (4) years of clinical research experience with a minimum of three (3) years clinical monitoring experience with pharmaceutical or medical device trials.
- Good knowledge of ICH GCP and a strong interest in clinical research.
- Good proficiency in providing clear direction and guidance to others.
- Excellent professional written and oral communication skills.
- Excellent organizational skills and attention to detail.
- Good level of computer literacy, e.g., proficiency in the use of electronic data capture systems, MS Office applications such as Word, Excel, PowerPoint, Outlook, etc.
- Physical location near a US airport (Dallas or Chicago or somewhere in between) and ability to travel approximately 70% of the time.