Clinical Research Associate Job at ELIXIR MD™ Inc, Irvine, CA

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  • ELIXIR MD™ Inc
  • Irvine, CA

Job Description

Job Description

Clinical Research Associate (CRA)

Department: R&D

Employment Type: Full-Time

About the Role

ELIXIR MD Inc. is seeking an experienced  Clinical Research Associate (CRA)to support our growing portfolio of clinical studies across surgical recovery, aesthetic outcomes, and photomedicine. You’ll manage key aspects of clinical trials from start-up through close-out—ensuring compliance, data integrity, and alignment with research goals that advance our mission to redefine post-operative care.

This is a high-impact, cross-functional role ideal for someone with strong site monitoring experience, analytical rigor, and the ability to manage clinical documentation in fast-paced, regulated environments.

Key Responsibilities

  • Draft, review, and manage  study start-up documents , including informed consent forms, protocols, and source documents.
  • Coordinate the  initiation and onboarding of clinical trial sites.
  • Perform  monitoring visits to ensure proper data collection, subject protection, and GCP compliance.
  • Review case report forms (CRFs) for  data accuracy, completeness , and protocol adherence.
  • Maintain  trial master files , ensuring all documentation is audit-ready and aligned with FDA/IRB standards.
  • Serve as a  liaison between clinical sites and internal stakeholders , supporting troubleshooting and communication throughout the study lifecycle.
  • Ensure compliance with  GCP, ICH, IRB , and internal SOPs.
  • Support data cleaning and preparation for analysis, regulatory submission, and publication.

Qualifications

  • Bachelor’s degree in  Life Sciences Public Health Biomedical Engineering , or related field.
  • Minimum 5 years of experience in clinical research, with hands-on  site monitoring experience.
  • Familiarity with medical device clinical trials and FDA requirements strongly preferred.
  • Demonstrated understanding of  clinical trial design , patient safety, and ethical research practices.

Skills & Competencies

  • Self-motivated with the ability to  work independently and manage multiple study timelines.
  • Detail-oriented with strong  documentation and reporting discipline .
  • Excellent written and verbal  communication skills , with the ability to translate clinical findings into actionable feedback.
  • Ability to  interpret clinical data and scientific literature with sound judgment.
  • Proficient in  Microsoft Office , CTMS platforms, and eTMF systems.
  • Willingness to travel for site visits (~20–30% as needed).

Compensation & Benefits

  • Salary Range: $85,000 – $130,000
  • Equity & Bonus: Eligibility for equity participation and performance-based bonuses.
  • Benefits Package Includes:
  • Professional development opportunities
  • Travel reimbursement and company-issued equipment

Life at ELIXIR MD Inc.

At ELIXIR MD Inc., we are building the future of surgical recovery. We believe in empowering clinicians with science-backed, patient-focused innovations that accelerate healing and elevate care. Our team thrives on purpose, creativity, and the desire to leave a lasting impact on the world of medicine. As part of our global initiative, Project Sunrise, we are donating 100 ELIXIR MD™ systems to top institutions worldwide to reach our goal of reducing post-operative recovery time to under 48 hours by 2030.

Diversity & Inclusion

ELIXIR MD Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees and applicants—regardless of race, color, religion, gender identity, age, disability, or veteran status.

Job Tags

Full time, Work at office, Worldwide,

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