Clinical Research Associate (CRA)

Clinical Affairs        ·       Irvine, CA       ·       Full time

Job Title: Clinical Research Associate (CRA)
FLSA: Salaried Exempt
Department: Clinical Affairs
Reports To: Clinical Project Manager
To apply, e-mail your resume to careers@axonics.com

Job Responsibilities:

The CRA will support the department with external communication, maintaining relationships with investigational sites, and complete assigned deliverables for the team. The CRA may support study management activities for clinical studies managed by Clinical Affairs and ensure the clinical studies are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

General Description and Duties:

To perform this job successfully, an individual must be able to perform each essential task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required to perform this job effectively.

• Supports study execution (both internally and externally) is in accordance with the study protocol, Instructions for Use, FDA regulations, Good Clinical Practices (GCP), and Standard Operating Procedures (SOPs), as applicable
• Completes all delegated tasks associated with clinical study execution
• Supports activities to meet project milestones
• Identifies, resolves, and/or escalates issues that have a significant impact to the study execution
• Contributes to the development of study documents for study conduct (training, initiation, enrollment, follow up, closeout)
• Supports site management activities (e.g. Investigator credentialing and retention of essential documents)
• Supports remote and on-site monitoring activities
• Maintains all relevant documentation and communications as part of study files
• Supports the development, adherence, and revision of clinical operations or project specific documents (for example: SOPs, work plans/practices, training guides)

Projects and Other Duties:

• Other duties or projects as requested by the manager

Position Qualifications

• Ability to problem solve
• Ability to understand relevant clinical data
• Ability to convey accurate, concise communication
• Strong organization skills and attention to detail
• Broad knowledge and understanding of the design and critical review of clinical studies
• Knowledge of Trial Master Files and essential documents
• Knowledge of monitoring clinical studies
• Ability to work effectively in teams
• Excellent verbal and written communication skills required
• Advanced skills with Microsoft Office Suite

Minimum Education:

• Bachelor’s degree preferred

Minimum Experience:

• Minimum three years’ experience in clinical research within the Medical Device or Biotech industry
• Knowledge of clinical research compliance including GCP, ICH-E6, ISO-14155, Code of Federal Regulations
• Experience with navigating an electronic data capture (EDC) system

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