Clinical Research Associate

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.

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.
• 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.

Job Type: Contract

Pay: $68,143.94 - $82,065.82 per year

Experience:

• Neuroscience: 1 year (Required)

Work Location: Remote