Regional Clinical Research Associate

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

📋 Description

• Execute designated monitoring tasks in line with Teleflex protocols and relevant regulations.

• Oversee all monitoring functions for assigned clinical trials.

• Plan and perform monitoring activities either onsite or remotely within defined timeframes.

• Detect data inconsistencies and compliance issues.

• Share findings with site research personnel.

• Collaborate effectively with Research Coordinators and Investigators.

• Prepare for monitoring visits and escalate significant observations.

• Act as a resource for site staff.

• Provide training and mentorship to Teleflex staff on monitoring protocols.

• Finalize monitoring visit reports and action items.

• Support team, department, and study-related initiatives.

⛳️ Requirements

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

• At least five years of experience as a CRA in the medical device or pharmaceutical sector or with a CRO.

• Proven knowledge and proficiency in the relevant therapeutic area.

• Experience in Vascular Interventional Cardiology is highly preferred.

• Background in conducting monitoring activities for first-in-human, investigational device exemption, post-approval, or post-market studies.

• Strong compliance orientation and understanding of current GCP/ICH guidelines and FDA regulations.

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

• Comprehensive knowledge of medical terminology.

• Capability to work independently in a regional area with minimal oversight.

• Strong organizational and problem-solving abilities.

• Excellent interpersonal communication skills.

• Ability to communicate effectively regarding adherence to protocol and regulatory standards.

🏝️ 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.