Regional Clinical Research Associate

This is a fully remote position, open to applicants in Virginia.

📋 Description

• Execute designated monitoring tasks in line with Teleflex protocols and relevant regulations to assess protocol adherence, data integrity, and participant safety through the examination of regulatory documents, medical records, reported data, and device storage when applicable.

• Oversee all monitoring functions for assigned clinical trials, including:

• o Organizing and performing monitoring activities either onsite or remotely within established timelines and based on the risk-based monitoring strategy and Teleflex protocols.

• o Detecting data inconsistencies and compliance issues, presenting findings to site research personnel, offering retraining when necessary, providing problem-solving strategies, and communicating results to the study team and department management through issue escalation and/or in the monitoring visit report.

• o Collaborate with Research Coordinators and Investigators to carry out monitoring visits, offer retraining, and address compliance issues as needed.

• o Work in conjunction with the Teleflex Clinical Studies project team members to prepare for monitoring visits, escalate significant findings during monitoring visits, and proactively share insights regarding site performance.

• o Report findings to site personnel and provide clear instructions for resolution. Review data queries with site staff to ensure understanding and resolution.

• o Act as a resource for site personnel between monitoring visits to clarify data queries, action items, and study visit preparations.

• o Mentor and train Teleflex staff on monitoring protocols and practices.

• o Conduct site training and co-monitoring visits as requested by management.

• o Complete monitoring visit reports, action items, and follow-up letters per Teleflex standards.

• o Support team, department, and study-related initiatives as requested, including audits, investigator meetings, training, etc.

• o Liaise with Clinical, Regulatory, Sales, and clinical site staff as required to fulfill the above responsibilities.

⛳️ Requirements

• Bachelor's or advanced degree in life sciences, nursing, or other health-related fields.

• A minimum of five years’ experience as a Clinical Research Associate (CRA) in the medical device or pharmaceutical sector or with a Contract Research Organization (CRO).

• Proven expertise and knowledge in relevant therapeutic areas, with a strong preference for Vascular Interventional Cardiology.

• Experience in executing monitoring tasks for first-in-human, investigational device exemption, post-approval, and/or post-market studies.

• Strong emphasis on compliance and a deep understanding of current GCP/ICH guidelines and FDA regulations, specifically 21 CFR Parts 11, 50, 54, 56, 812, and 820, as well as ISO requirements governing medical device clinical trials.

• Current certification as a Certified Clinical Research Associate (CCRA) or a Certified Clinical Research Professional (CCRP).

• Comprehensive knowledge of medical terminology.

• Ability to operate independently in a regional area with minimal oversight.

• Exceptional organizational and problem-solving capabilities, including the demonstrated ability to assess challenging situations and devise alternative solutions creatively and independently.

• Strong interpersonal skills, with the capacity to effectively interface and communicate with both internal and external collaborators, including physicians, site research personnel, project teams, and management.

• Ability to engage constructively in discussions regarding adherence to protocol and regulatory standards.

• Responsible for maintaining a suitable home office setup, including a dedicated workspace to accommodate work duties and Teleflex-supplied equipment.

🏝️ Benefits

• Medical, prescription drug, dental, and vision insurance

• Flexible spending accounts

• Participation in a 401(k) savings plan

• Various paid time off benefits, including PTO, short- and long-term disability, and parental leave