Job description
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.
Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.
Summary:
The Clinical Research Associate (CRA) position at Calyxo offers a unique opportunity to build a dynamic career in clinical research while supporting innovative technologies that improve patient outcomes and have a meaningful impact in the treatment of kidney stones.
The CRA is responsible for monitoring and overseeing the conduct of clinical trials to ensure compliance with the study protocol, Good Clinical Practice (GCP), and all applicable regulatory requirements. The CRA is a key contributor to the successful execution of Calyxo’s clinical research activities.
In This Role, You Will:
- Conduct qualification, initiation, monitoring, and closeout visits at research sites.
- Responsible for site management and primary point of contact for site staff including coordinators, clinical research physicians, and their site staff.
- Verify adequate investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff.
- Conduct source documentation verification and review of medical records against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements.
- On-site and remote monitoring activities with a risk-based monitoring approach to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward.
- Verification that the investigator is enrolling only in eligible subjects.
- Regulatory document review and filing in Trial Master File
- Perform medical device and/or investigational product accountability and inventory.
- Verification and review of adverse events, serious adverse events, concomitant medications, and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
- Oversee the clinical research site’s patient recruitment and retention success and provide recommendations for improvement when needed.
- Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
- Escalate critical issues or ongoing non-compliance to the appropriate internal stakeholders and/or project leadership in accordance with SOPs and regulatory guidelines to ensure subject safety and data integrity.
Who You Will Report To:
- See organizational chart
Requirements:
- Must have a minimum of a bachelor’s degree in a health or science related field.
- Minimum of 2 years’ experience in industry-sponsored clinical trials as a CRA or Clinical Research Coordinator (CRC).
- Minimum of 1 year (12 months) independent CRA monitoring experience in a full-time CRA role with a contract research organization (CRO) or industry sponsor.
- Work location: Remote; candidate.
- Travel: Ability to travel up to 50-60% nationwide
- Full time
- Proven ability to establish and maintain strong, collaborative relationships with site staff, including study coordinators and Principal Investigators (PIs).
- Strong self-management skills with the ability to work autonomously and prioritize tasks effectively in a remote setting.
- Demonstrated ability to engage constructively in a team setting, fostering collaboration, and contributing to achieving project milestones.
- Effective communication and conflict-resolution skills.
- Knowledge of Microsoft Office.
- Broad knowledge of medical terminology.
- Basic knowledge of medical device approval pathways.
- Excellent oral and written communication skills.
- Strong presentation skills.
- Must be detail oriented.
- Knowledge of GCP, ICH guidelines, and applicable regulatory requirements.
- Compliance with relevant county, state, and Federal rules regarding vaccinations.
Preferred Qualifications:
- Live within one hour of a major airport
- Prior urology clinical trial experience
What We Offer:
At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.
We also offer an attractive compensation package, which includes:
- A competitive base salary of $80,000 - $92,000 and variable incentive plan
- Stock options – ownership and a stake in growing a mission-driven company
- Employee benefits package that includes 401(k), healthcare insurance and paid vacation
Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth.
Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics
Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form 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 [email protected]. If you receive a request for information from any other domain, please contact us directly at [email protected] 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.
