[Hiring] Clinical Research Associate REMOTE USA

Position: Clinical Research Associate

Date Posted: August 21, 2025

Industry: Medical Devices / Clinical Research

Employment Type: Full Time

Experience: Minimum 2 years in industry-sponsored clinical trials as a CRA or Clinical Research Coordinator (CRC); at least 1 year of independent CRA monitoring experience in a full-time CRA role

Qualification: Bachelor’s degree in a health- or science-related field (required)

Salary: $80,000 – $92,000 (plus variable incentive plan)

Location: United States (Remote)

Company: Calyxo, Inc.

Description:
About Calyxo, Inc.
Calyxo is a medical device company based in Pleasanton, California, founded in 2016 to improve treatment options for kidney stones. Our leadership team has deep commercial and clinical experience in bringing transformative urology devices to market. We’re a mission-driven company that values innovation, teamwork, and measurable impact on patient care.

Summary
The Clinical Research Associate (CRA) will play a central role in supporting Calyxo’s clinical trial operations, ensuring studies are conducted in line with the protocol, Good Clinical Practice (GCP), and applicable regulations. This position offers a chance to grow a career in clinical research while supporting novel technologies that improve patient outcomes.

In This Role, You Will:

• Conduct site qualification, initiation, monitoring, and closeout visits (on-site and remote).
• Serve as the primary site contact, managing relationships with site coordinators, physicians, and site staff.
• Confirm investigator qualifications, training, and that sites have necessary facilities, staff, labs, and equipment.
• Perform source data verification and compare medical records to case report form entries, identify discrepancies, and ensure robust documentation and protocol adherence.
• Use a risk-based monitoring approach to detect site deviations/deficiencies and drive corrective and preventive actions to restore compliance.
• Ensure subjects enrolled meet eligibility criteria and confirm accurate reporting of concomitant medications and events.
• Oversee regulatory document review and Trial Master File maintenance.
• Manage investigational product and medical device accountability and inventory at sites.
• Review adverse events and serious adverse events for accurate classification and reporting according to protocol.
• Support site recruitment and retention efforts and recommend improvements when needed.
• Prepare monitoring reports and follow-up letters summarizing findings, deviations, and recommended remediation.
• Escalate critical or persistent non-compliance issues to internal stakeholders and project leadership per SOPs and regulations to protect subject safety and data integrity.

Who You Will Report To:
See organizational chart.

Requirements:

• Bachelor’s degree in a health- or science-related discipline.
• Minimum 2 years’ participation in industry-sponsored clinical trials as a CRA or CRC.
• At least 12 months of independent CRA monitoring experience in a full-time CRA role (CRO or sponsor).
• Ability to travel nationwide up to 50–60%.
• Proven ability to build and maintain collaborative relationships with site staff and Principal Investigators.
• Strong self-management skills and the ability to work autonomously in a remote environment while prioritizing tasks effectively.
• Effective team collaboration, communication, and conflict-resolution skills.
• Proficiency with Microsoft Office and familiarity with medical terminology.
• Basic understanding of medical device regulatory/approval pathways.
• Excellent oral and written communication and presentation skills.
• Strong attention to detail.
• Knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
• Compliance with applicable county, state, and federal vaccination rules.

Preferred Qualifications:

• Reside within one hour of a major airport.
• Prior experience with urology clinical trials.

What We Offer
At Calyxo you’ll join an experienced, high-performing team in an inclusive environment that supports development and learning. You’ll face dynamic challenges that help you grow technically and professionally while contributing to meaningful improvements in patient care.

We Also Offer An Attractive Compensation Package, Which Includes:

• Competitive base salary of $80,000 – $92,000 plus a variable incentive plan.
• Stock options for ownership in a growing, mission-driven company.
• Benefits including 401(k), healthcare insurance, and paid vacation.

Equal Opportunity & Legal Authorization
Calyxo is an equal opportunity employer committed to diversity and inclusion. Legal authorization to work in the United States is required. In compliance with federal law, hires will verify identity and employment eligibility and complete the required employment eligibility verification upon hire.

Disclaimer
At Calyxo, we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:

• Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
• Verification of Identity: We do not extend job offers without first meeting candidates, either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
• Beware of Scams: Calyxo will never request sensitive personal information, such as your full name, address, phone number, or identification documents, via email or online forms before an official interview. Calyxo representatives will always contact you using an email format of firstname.lastname@calyxoinc.com. If you receive a request for information from any other domain, please contact us directly at info@calyxoinc.com to verify the legitimacy of the communication.

We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.

Disclaimer: The job details above are structured for clarity and based on publicly available content from recruiters/Company pages. All rights remain with the original source; names may be withheld for confidentiality. We are not involved in the hiring process.