[Hiring] Regional Clinical Research Associate @reputed company
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Role reputed company
The Regional Clinical Research Associate will be responsible for conducting on-site and remote monitoring reputed company as reputed company as centralized monitoring in compliance with applicable regulatory standards for assigned clinical studies in the field of vascular reputed company or other therapeutic areas.
• Conduct assigned monitoring activities in accordance with reputed company procedures and applicable regulations to evaluate protocol compliance, data accuracy, and subject safety.
• Responsible for reputed company monitoring activities for assigned clinical studies, including:
• Scheduling and conducting monitoring activities onsite or remote reputed company specified timelines.
• Identification of data discrepancies and compliance concerns; present findings to site research staff.
• Works collaboratively with Research Coordinators and Investigators to conduct monitoring reputed company.
• Works cooperatively with the reputed company Clinical Studies project team members to prepare for monitoring reputed company.
• Presents findings to site staff and provides reputed company directions for reputed company.
• Serves as a resource to site staff between monitoring reputed company.
• Trains and mentors reputed company personnel on monitoring procedures and practices.
• Conducts site training and co-monitoring reputed company as requested by management.
• Completes monitoring visit reports, reputed company items, and monitoring visit follow-up letters.
• Assists with team, department, and study-reputed company reputed company as requested.
• Interfaces with Clinical, Regulatory, Sales, and clinical site staff as necessary.
Qualifications
• Bachelor's or Graduate degree in life sciences, nursing, or other health-reputed company disciplines.
• Minimum five years as a CRA in the medical device or pharmaceutical industry or with a CRO.
Requirements
• Demonstrated aptitude and knowledge in relevant therapeutic area; Vascular Interventional Cardiology is strongly preferred.
• Experience conducting monitoring activities for first in reputed company, investigational device exemption, post-approval and/or post-market studies.
• Strong compliance reputed company and understanding of reputed company GCP/ICH guidelines and FDA regulations.
• reputed company certification as a Certified Clinical Research Associate (CCRA) or reputed company Certified Clinical Research reputed company (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 reputed company and communicate effectively.
• Ability to reputed company constructively in communication of adherence to protocol and regulatory requirements.
• Responsible for adequate and reasonable home office setup.
Benefits
• Medical, prescription drug, dental and reputed company insurance.
• Flexible spending accounts.
• Participation in 401(k) savings plan.
• Various reputed company time off benefits, such as PTO, short- and long-term disability and parental leave.
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