Clinical Research Associate

Clinical         ·        Carlsbad, CA           ·         Full time

The Clinical Research Associate (CRA) position works in the Clinical Affairs department to execute research and administrative strategies to achieve the Company’s clinical research goals. Major responsibilities include support clinical trial development and execution, monitoring, site training, and ensuring compliance with clinical protocol and Good Clinical Practice.

Responsibilities:

• Assist in development and review of clinical protocols, case report forms (CRFs) and monitoring plans for pre- and post-market studies
• Develop and procure study materials and distribute to sites
• Supervise collection of regulatory documents from clinical sites
• Support site related activities including contracting, budget discussions, assessment of qualifications, maintaining records, various submissions
• Ensure proper reports (SQV, SIV, IMV) are current and maintained for each site
• Conduct initiation, interim, close out and monitoring visits as required
• Support tracking of study related timelines and budgets
• Plan, coordinate, prepare presentation materials and present information at Investigator meetings
• Assist in development of departmental SOPs, personnel, and training programs
• Review study data and resolution of queries
• Assist in writing and review clinical study reports
• Support patient recruitment and retention activities
• Work with other internal departments as needed, in order to meet company goals
• Other duties as deemed necessary by the company

Requirements:

• Bachelor’s Degree in a scientific discipline, or equivalent experience within a scientific/medical field (medical technician, nursing, allied health)
• Minimum one to two (1-2) years of experience working as a clinical research associate, preferably with a medical device company
• Thorough knowledge of FDA regulations and ISO 14155:2020 standard
• Working knowledge of medical and scientific terminology
• Ability to travel approximately 30%
• Demonstrated ability to handle multiple projects simultaneously, and meet timelines in a dynamic workplace environment
• Demonstrated ability to work in a team environment
• Excellent verbal and written communication skills

Pay Range: $65,000 – $110,000 per year

Please click here to apply.