Regional Clinical Research Associate
Job Description:
• Conduct assigned monitoring activities in accordance with Teleflex procedures and applicable regulations.
• Schedule and conduct monitoring activities onsite or remote within specified timelines.
• Identify data discrepancies and compliance concerns.
• Work collaboratively with Research Coordinators and Investigators.
• Present findings to site staff and provide clear directions for resolution.
• Train and mentor Teleflex personnel on monitoring procedures and practices.
• Complete monitoring visit reports, action items, and monitoring visit follow-up letters per Teleflex procedures.
• Assist with team, department, and study-related projects as requested.
Requirements:
• Bachelor's or Graduate degree in life sciences, nursing, or other health-related disciplines.
• Minimum five years as a CRA in the medical device or pharmaceutical industry or with a CRO.
• Demonstrated aptitude and knowledge in relevant therapeutic area.
• Experience conducting monitoring activities for first in human, investigational device exemption, post-approval and/or post-market studies.
• Strong compliance focus and understanding of current GCP/ICH guidelines and FDA regulations.
• Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP).
• Strong knowledge of medical terminology
• Ability to work independently in a regional area with minimal supervision
• Excellent organizational and problem-solving skills.
• Excellent interpersonal skills, ability to interface and communicate effectively with internal and external collaborators.
Benefits:
• medical, prescription drug, dental and vision insurance
• flexible spending accounts
• participation in 401(k) savings plan
• various paid time off benefits, such as PTO, short- and long-term disability and parental leave
Apply Now
Apply Now
• Conduct assigned monitoring activities in accordance with Teleflex procedures and applicable regulations.
• Schedule and conduct monitoring activities onsite or remote within specified timelines.
• Identify data discrepancies and compliance concerns.
• Work collaboratively with Research Coordinators and Investigators.
• Present findings to site staff and provide clear directions for resolution.
• Train and mentor Teleflex personnel on monitoring procedures and practices.
• Complete monitoring visit reports, action items, and monitoring visit follow-up letters per Teleflex procedures.
• Assist with team, department, and study-related projects as requested.
Requirements:
• Bachelor's or Graduate degree in life sciences, nursing, or other health-related disciplines.
• Minimum five years as a CRA in the medical device or pharmaceutical industry or with a CRO.
• Demonstrated aptitude and knowledge in relevant therapeutic area.
• Experience conducting monitoring activities for first in human, investigational device exemption, post-approval and/or post-market studies.
• Strong compliance focus and understanding of current GCP/ICH guidelines and FDA regulations.
• Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP).
• Strong knowledge of medical terminology
• Ability to work independently in a regional area with minimal supervision
• Excellent organizational and problem-solving skills.
• Excellent interpersonal skills, ability to interface and communicate effectively with internal and external collaborators.
Benefits:
• medical, prescription drug, dental and vision insurance
• flexible spending accounts
• participation in 401(k) savings plan
• various paid time off benefits, such as PTO, short- and long-term disability and parental leave
Apply Now
Apply Now