Job Description
Join our pioneering team at MediTech Innovations as a Clinical Research Coordinator and drive breakthroughs in medical science. We're seeking a meticulous professional to manage complex clinical trials from protocol development to final report submission. Enjoy a collaborative environment cutting-edge facilities, and comprehensive benefits package including health insurance, retirement plans, and professional development stipends. This role offers the unique opportunity to contribute to life-changing therapies while advancing your career in a fast-growing biotech hub.
Responsibilities
- Design and implement clinical trial protocols in compliance with FDA regulations and ICH-GCP guidelines
- Recruit, screen, and enroll eligible study participants while maintaining ethical standards
- Monitor trial progress, collect and analyze data, and prepare regulatory submissions
- Coordinate multidisciplinary teams including physicians, statisticians, and data managers
- Ensure protocol adherence through site visits and source document verification
- Manage study budgets, timelines, and vendor relationships
- Prepare comprehensive final study reports and regulatory documentation
Qualifications
- Bachelor's degree in Nursing, Life Sciences, or related field (Master's preferred)
- 3+ years clinical research coordination experience in pharmaceutical or biotech setting
- Certified Clinical Research Professional (CCRP) or SOCRA certification required
- Proficiency in electronic data capture systems (e.g., Medidata Rave, Veeva Vault)
- Deep understanding of FDA 21 CFR Part 312 and ICH-GCP guidelines
- Exceptional organizational skills with ability to manage multiple concurrent trials
- Strong written communication skills for preparing regulatory documents
- Experience with IRB submissions and protocol amendments