Job Description
- 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
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