Clinical Research Associate - Remote

reputed company. 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. reputed company is led by executives and investors with a proven track record of commercializing reputed company-shifting devices to meet unmet needs reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company.
• Verification that the investigator is enrolling only in eligible subjects.
• Regulatory document review and filing in Trial Master File
• reputed company 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
• reputed company the clinical research site’s patient recruitment and retention success and provide recommendations for improvement reputed company 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 reputed company.

Who You Will Report To:

• See organizational chart

Requirements:

• Must have a minimum of a bachelor’s degree in a health or science reputed company 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% reputed company
• 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 reputed company Office.
• Broad knowledge of medical terminology.
• Basic knowledge of medical device approval reputed company.
• 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 reputed company one hour of a major airport
• Prior urology clinical trial experience

reputed company Offer: At Calyxo, you will be part of a knowledgeable, high-achieving, reputed company and fun team. You will work in a diverse work environment with reputed company, 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 of Apply tot his job Apply To this Job