Regional Clinical Research Associate

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

📋 Description

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

• Oversee all monitoring operations for assigned clinical trials, which includes:

• o Planning and executing monitoring activities either onsite or remotely within established timelines, aligning with the risk-based monitoring strategy and Teleflex procedures.

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

• o Collaborating with Research Coordinators and Investigators to carry out monitoring visits, provide retraining, and address compliance concerns as needed.

• o Working in partnership with the Teleflex Clinical Studies project team members to prepare for monitoring visits, escalating significant findings during visits, and proactively contributing insights on site performance.

• o Presenting findings to site personnel and offering clear guidance for resolution. Reviewing data queries with site staff to ensure understanding and resolution.

• o Acting as a resource for site personnel between monitoring visits to offer clarification and insights regarding data queries, action items, and study visit preparation.

• o Training and mentoring Teleflex staff on monitoring methods and practices.

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

• o Completing monitoring visit reports, action items, and follow-up letters in accordance with Teleflex protocols.

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

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

⛳️ Requirements

• Bachelor's or Graduate degree in life sciences, nursing, or related health disciplines.

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

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

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

• Strong compliance orientation and understanding of existing GCP/ICH guidelines and FDA regulations, specifically 21 CFR Parts 11, 50, 54, 56, 812, and 820, as well as ISO requirements applicable to medical device clinical trials.

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

• Strong understanding of medical terminology.

• Excellent organizational and problem-solving abilities, demonstrating the capacity to assess challenging situations and creatively and independently develop alternative solutions.

• Outstanding interpersonal skills, with the ability to effectively interface and communicate with internal and external collaborators, including physicians, site research staff, project teams, and management.

• Capacity to engage constructively when communicating adherence to protocol and regulatory requirements.

🏝️ 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.