Senior Clinical Research Monitor: Field Trials & Training Lead

Edwards Lifesciences; Yuma (AZ); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences is seeking a Clinical Affairs professional to monitor clinical studies, ensure GCP compliance, and contribute to protocol development. The role involves training, mentoring, and data quality oversight across trials, with substantial travel to field sites.

You will collaborate with investigators, regulatory bodies, and study sponsors to optimize patient outcomes and ensure regulatory adherence. A Bachelor's degree and 5 years in related roles are required.

Qualifications

• Bachelor's degree or equivalent in related field with 5 years of field monitoring, quality assurance and regulatory compliance experience.
• Ability to travel up to 75% domestically.

Responsibilities

• Field monitoring of studies and data collection for clinical trials, ensuring documentation aligns with study parameters and regulatory requirements.
• Developing and delivering training on GCPs, protocols, and regulatory documentation; mentoring new employees.
• Overseeing trial activities, identifying trends in protocol compliance and data quality, and proposing process improvements.
• Contributing to development of clinical protocols and informed consent documents.
• Validating investigational device accountability and maintaining regulatory documents.

Skills

Field monitoring

Quality assurance

Regulatory compliance

Travel up to 75%

Education

Bachelor's degree or equivalent

Tools

MS Office

Job description

Edwards Lifesciences is seeking a Clinical Affairs professional to monitor clinical studies, ensure GCP compliance, and contribute to protocol development. The role involves training, mentoring, and data quality oversight across trials, with substantial travel to field sites.

You will collaborate with investigators, regulatory bodies, and study sponsors to optimize patient outcomes and ensure regulatory adherence. A Bachelor's degree and 5 years in related roles are required.