Clinical Research Monitor

1 Edwards Way, Irvine, CA 92614, USA

Full-TimeDepends on ExperienceMid-LevelBachelors

Job Description

Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form. Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Contribute to the development of clinical protocols, informed consent forms, and case report forms. Also contribute to team projects. Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition. Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.

Where is this job?

This job is located at 1 Edwards Way, Irvine, CA 92614, USA

Job Qualifications

Minimum 5 years of previous field monitoring experience
Experience working in a medical device or regulated industry
Clinical Research Certification (ACRP or SoCRA preferred)
Experience with electronic data capture

Required Skills

Presentation skills
MS Word
Technical writing skills
Time Management Skills
MS Excel skills
Excellent analytical skills
CRF development

Soft Skills

Process Improvement
Prioritizing skills
Detail Oriented and Organized
Verbal and Written Communication
Multi tasker
Flexibility and adaptability
Driven for excellence

Compensation

According to JobzMall, the average salary range for a Clinical Research Monitor in 1 Edwards Way, Irvine, CA 92614, USA is:

$43,000 - $90,000 per year.

Additional Information

Edwards Lifesciences is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Required LanguagesEnglish

Job PostedAugust 2nd, 2021

Apply BeforeMay 22nd, 2025

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