Calyxo, Inc. is a medical device company addressing 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.
Requirements
- 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.
- Knowledge of Microsoft Office.
- Broad knowledge of medical terminology.
- Basic knowledge of medical device approval pathways.
- Knowledge of GCP, ICH guidelines, and applicable regulatory requirements.
Responsibilities
- 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.
- 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
- Verification and review of adverse events, serious adverse events, concomitant medications, and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
Other
- Must have a minimum of a bachelor’s degree in a health or science related field.
- 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.
