Clinical Trial Associate

Clinical Trial Associate, Irvine, CA

Job Title: Clinical Trial Associate

FLSA: Salaried Exempt

Department: Clinical Affairs

Reports To: Clinical Project Manager

To apply, e-mail your resume to This email address is being protected from spambots. You need JavaScript enabled to view it.

Job Responsibilities:

The Clinical Trial Associate will support projects and studies within the Clinical Affairs department. Study-related tasks will be conducted 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 and/or escalates issues that have a significant impact to the study execution
Supports site management activities for training (e.g., study/site initiation, continuing enrollment, and closeout).
Supports study conduct and maintains essential documents (e.g., correspondence with sites and review/retention of essential documents)
Supports internal data review, including resolution of queries and review of data outliers
Maintains all relevant documentation and communications as part of study files
Supports the activities of clinical operations or project specific documents (for example: SOPs and work instructions)

Projects and Other Duties:

Other duties 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
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 two (2) years’ experience in clinical research within the Medical Device, Pharmaceutical, 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

Salary:

Aligning our overall business objectives with performance and merit based pay, Axonics offers competitive salaries, performance-based incentives, and Employer paid benefits programs to address the diverse individual needs of our employees and their families. At Axonics, our employees come first!
For California, the base pay range for this position is $75,000 to $90,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Axonics is an Equal Opportunity Employer, included protected Veterans and individuals with disabilities.

Questions?

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