Job Description
Join MedTech Innovations as a Senior Clinical Research Coordinator and become a pivotal force in advancing medical breakthroughs. We're seeking a dedicated professional to oversee complex clinical trials from protocol development to final report submission. Our collaborative environment empowers you to work with world-class researchers while ensuring regulatory compliance and patient safety.
This role offers the opportunity to shape the future of healthcare by managing cutting-edge studies in oncology and immunotherapy. You'll lead cross-functional teams, troubleshoot operational challenges, and contribute to life-changing therapies. We provide competitive benefits, professional development funding, and a culture that values innovation and patient-centered care.
Responsibilities
- Design and implement comprehensive clinical trial protocols adhering to FDA regulations and ICH-GCP standards
- Manage site initiation, monitoring, and closeout activities for multi-center oncology trials
- Serve as primary liaison between investigators, sponsors, and regulatory bodies
- Oversee data collection, quality assurance, and adverse event reporting systems
- Mentor junior coordinators and conduct staff training on SOPs and regulatory updates
- Prepare regulatory submissions and ensure compliance with 21 CFR Part 11
- Analyze trial metrics and optimize operational efficiencies
Qualifications
- Master's degree in Clinical Research, Nursing, or related health science field
- 5+ years of clinical trial coordination experience in oncology/immunotherapy
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Expertise in EDC systems (e.g., Medidata Rave, Oracle Inform)
- Demonstrated success in managing multi-center trials with 20+ sites
- Strong knowledge of FDA regulations, ICH-GCP, and clinical trial methodologies
- Exceptional problem-solving skills and attention to detail
- Valid CPR certification and ability to travel 15-20%