Clinical Research Associate

Description

• Prepare and submit visit reports, follow-up letters, and other documentation promptly.
• Coordinate, organize, and manage clinical study coordinator teleconferences as needed.
• Attend project meetings and provide updates on site status and progress.
• Maintain accurate and up-to-date study files, including regulatory documents and monitoring records.
• Conduct site staff training and retraining on study protocol requirements and procedures.
• Serve as the primary point of contact for investigators and site staff.
• Verify the accuracy and completeness of study data through source data review and verification.
• Manage site-level queries, protocol deviations, and issues, escalating as necessary.
• Support site audits and inspections.
• Collaborate closely with sites to complete required site visits and perform site management activities to meet project timelines and deliverables.
• Ensure all site management and monitoring activities comply with ICH-GCP, SOPs, Clinical Monitoring Plan, Protocol, study plans, local laws, and regulations.
• Support site feasibility assessments and patient recruitment strategies.
• Ensure events are properly followed to completion.
• Identify risks and recommend mitigation strategies.
• Ensure timely and accurate reporting of adverse events, serious adverse events, and data safety.
• Lead and conduct presentations.
• Act as a liaison between sites and sponsors, ensuring effective communication and issue resolution.
• Work with sites to adapt, drive, and track the subject recruitment plan to enhance predictability.
• Ensure timely and accurate updating of data systems by sites.

Requirements

• Ability to lead and conduct presentations.
• Experience managing serious adverse events in collaboration with safety surveillance.
• Experience managing aspects of CRO functions is a plus.
• Ability to travel up to 80%, including overnight stays.
• In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, such as ICH-GCP guidelines.
• Effective organizational, communication, and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Experience in clinical trial management systems (CTMS), EDC platforms, and Microsoft Office suite.
• Experience working in a fast-paced, collaborative environment.
• Bachelor’s Degree in a scientific discipline or healthcare preferred.
• Effective time and financial management skills.
• Minimum 5 years of onsite monitoring experience.
• Prior experience in patient recruitment & retention strategies and site relationship management.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance