Clinical Research Associate

*EXCITING NEW CRA OPPORTUNITY*

Clinical Research Associate - Full Time - East Coast &Central Travel

My Client

Join our Clients pioneering team, a rapidly growing CRO, focused on revolutionizing the treatment of Rare Diseases. They are dedicated to developing innovative solutions that improve patient outcomes and enhance quality of life. We are currently seeking a talented and motivated Clinical Research Associate (CRA) to join our Clients dynamic team and contribute to the success of their clinical research programs.

Position Overview:

As a Clinical Research Associate, you will play a crucial role in the planning, execution, and monitoring of clinical trials for innovative therapies. Working closely with cross-functional teams and external partners, you will ensure compliance with regulatory requirements, protocol adherence, and data quality standards. This position offers an exciting opportunity to be part of a collaborative team driving ground-breaking research in ophthalmology.

Responsibilities:

1. Clinical Trial Management: Oversee all aspects of clinical trial conduct, including site selection, initiation, monitoring, and closeout activities. Ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
2. Site Management: Establish and maintain strong relationships with investigational sites, investigators, and study staff. Conduct site qualification, initiation, and routine monitoring visits to assess protocol compliance, data integrity, and patient safety.
3. Data Management: Monitor and review clinical trial data to ensure accuracy, completeness, and quality. Work closely with data management teams to resolve data discrepancies and queries in a timely manner.
4. Regulatory Compliance: Assist with regulatory submissions and approvals, including preparation of clinical trial applications, investigator brochures, and informed consent documents. Ensure compliance with applicable regulatory requirements and ethical standards.
5. Risk Management: Identify potential risks and issues that may impact study timelines or data integrity. Develop risk mitigation strategies and implement corrective actions as needed to ensure the successful execution of clinical trials.
6. Documentation and Reporting: Maintain accurate and up-to-date trial documentation, including trial master files, monitoring reports, and regulatory submissions. Generate study progress reports and presentations for internal and external stakeholders.

Qualifications:

• Willing to travel to East Coast and Central American sites
• Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
• Minimum of 2 years of experience as a Clinical Research Associate, with a focus on medical device or ophthalmology trials.
• Experience in site management, monitoring, and data review for clinical trials.
• Excellent communication, interpersonal, and organizational skills.
• Ability to work independently and collaboratively in a fast-paced, start-up environment.
• Willingness to travel domestically for site visits and meetings, as needed.

Location: East Coast & Central

How to Apply:

If you are a motivated and experienced Clinical Research Associate looking to contribute to the success of a growing CRO, we encourage you to apply for this position. Please submit your resume to cburns@barringtonjames.com.