Clinical Research Associate

Ardence Consulting is recruiting for an unnamed medical device client seeking a Clinical Research Associate to support ongoing clinical trials. The role focuses on clinical trial monitoring, query closure, risk-based studies, TMF creation, and site management.

Responsibilities

Ensure site reporting/compliance

Conduct study startup, monitoring, closeout visits

Support the clinical team with investigator meetings

Assist in development of departmental SOPs, personnel, and training programs

Generate clinical study reports

Support query review and closure

Support review of regulatory binder

Maintenance of CRO

Support implementation and testing of EDC

Ensure patient enrollment/retention goals are met

Preferred

Experience with class III medical devices

Bilingual in Spanish

Class III medical device experience

Benefits

Remote work, with minimal travel.

Company

Life science consulting for pharmaceutical, biotech, and medical device companies

San Diego, CA, US

http://www.ardenceconsulting.com/

Founded in 2021

2-10 employees

Qualifications

BS Degree (Scientific or health-related field)

2+ years of clinical research experience (medical device experience is required)

Experience with class III medical devices

Bilingual in Spanish

Required skills

Represents the skills you have, click on the tags, Medical Device Clinical Research, Class III Medical Devices, Spanish

Preferred skills

Experience with class III medical devices, Bilingual in Spanish

Experience

2+ years