Sr. Clinical Research Associate

Senior Clinical Research Associate

Job Title: Sr. Clinical Research Associate

FLSA: Salaried Exempt

Department: Clinical Affairs

Reports To: Director, Clinical Operations

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Job Responsibilities:

The Sr. Clinical Research Associate will 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. This role will represent the company with frontline communication, relaying objectives, and maintaining relationships with investigational sites. The Sr. CRA is also a key team member that collaborates with a Contract Research Organization (CRO), Regulatory Affairs, Quality, and any other departments or vendors that interact with a clinical study.

General Description and Duties:

The tasks listed below are representative of the knowledge, skill, and/or ability required to perform this job effectively.

Ensures 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.
Study coordinating, planning, and logistics to ensure project milestones are met.
Identifies, resolves, and/or escalates issues that have a significant impact to the study execution.
Contributes to the development of protocol, Informed Consent Form, Case Report Forms, and any additional study documents for study conduct (training, initiation, enrollment, follow up, closeout).
Site management through the continuing oversight of all research staff (including verification of Investigator qualifications), facilities, and investigational products, as applicable.
Provide support for development and implementation of the Clinical Monitoring Plan.
Verifying that source records and data collection are accurate, complete, and maintained through remote and on-site monitoring.
Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the Investigator or internally.
Maintains all relevant documentation and communications as part of study files.
Review study data, compile data for review, creates tables and graphs under appropriate guidance, and assists with the preparation and review of clinical reports.

Projects and Other Duties:

Other duties or projects as requested by the manager.

Position Qualifications:

Ability to coordinate or manage multiple projects to meet project timelines/milestones.
Exercises independent judgment with problem-solving skills.
Ability to understand and discuss relevant clinical data.
Broad knowledge and understanding of the design and critical review of clinical studies.
Advanced knowledge of Trial Master Files and essential documents
Advanced knowledge of monitoring clinical studies and preparing for audits by regulatory bodies.
Ability to work effectively in teams.
Excellent verbal and written communication skills required.
Advanced skills with Microsoft Office Suite
Willingness to travel up to 50%

Minimum Education:

Bachelor's degree preferred

Minimum Experience:

5+ years of experience in clinical research within the Medical Device or Biotech industry
Advanced knowledge of clinical research compliance including GCP, ICH-E6, ISO-14155, Code of Federal Regulations
Experience with navigating, initiating, and minimal requirements of creating 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 $115,000 to $125,000 (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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