Job Description
Join MedTech Innovations, a leader in medical device clinical trials, as a Senior Clinical Research Coordinator. Lead groundbreaking studies in cardiovascular technology while advancing patient care through rigorous research protocols. We offer a dynamic environment where innovation meets compassion, with opportunities to present findings at global conferences and collaborate with industry pioneers.
Responsibilities
- Oversee multi-site clinical trials from protocol development to FDA submission
- Manage electronic data capture systems and ensure regulatory compliance (FDA/ICH-GCP)
- Coordinate investigator meetings and provide mentorship to junior CRCs
- Analyze adverse event reports and implement risk mitigation strategies
- Develop patient recruitment plans and maintain IRB documentation
- Collaborate with biostatisticians on clinical endpoint analysis
- Prepare study reports for FDA submissions and scientific publications
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- 3+ years' experience in medical device clinical trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Expertise in FDA 21 CFR Part 820 and ISO 13485 standards
- Proficiency with Medidata Rave or similar EDC platforms
- Strong data analysis skills (SAS/R preferred)
- Exceptional project management with PMP certification preferred
- Experience with cardiovascular device trials highly desirable