Clinical Research Associate

Tustin, CA

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Overview

Now hiring for a hungry Clinical Research Associate who has a generous spirit, is committed to creating change and is committed to the medical device industry. The Clinical Research Associate is located in Irvine, California and will be responsible for supporting the Project Managers and Monitors around pre-market clinical trials.

Responsibilities  

• Managing the conduct of clinical studies in accordance with federal regulations and good clinical practices guidelines.
• Understanding, Reading and preparing technical documentation including study protocols, informed consents, case report forms, and study training documents.
• Reviewing and reconciling site documentation, including site regulatory documents and patient medical records.
• Work with a central IRB and sites to ensure IRB approvals.
• Participate in data review.
• Interfacing with site staff, monitors, vendors, and/or CROs to execute operational activities.
• Working closely with Project Manager(s). 
• Supporting audit activities.
• Support budget and contract negotiations with clinical sites.
• Perform site qualification and selection process.
• Coordinate and participate in investigator meetings and site initiation visits, as well as conducting training of site staff.
• Develop and maintain trackers to support the management of clinical studies.

Experience

• Possesses knowledge of FDA regulations for clinical trials and clinical procedures.
• Creative problem solving; keen attention to details; outstanding organizational abilities.
• Strong collaborative skills with demonstrated ability to work with physicians, site coordinators and others within the company.
• High level of clinical expertise in various therapeutic areas (Preferred Areas: Neurovascular and Cardiovascular) and procedures associated with clinical research projects.
• Experience working in an FDA-regulated industry and conduct of clinical trials.
• Excellent written and oral communication skills.
• Field Monitor experience a plus.
• Clinical Trial Management System (CTMS) experience.
• Experience with audit inspections.
• Motivated individual with a high-energy level.
• Certified Clinical Research Associate (CCRA) certification.

Qualifications

• Bachelor’s degree in related field or equivalent experience (Life Science degree preferred).
• Must have a minimum of two (2) to four (4) years direct clinical research experience preferably in the medical device industry, in-house or field Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Clinical Trial Associate (CTA) or similar position.

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