Job Description
Join our pioneering team at MediTech Innovations, where cutting-edge medical research meets transformative patient care. We're seeking a Clinical Research Associate to drive the next generation of clinical trials in oncology and immunotherapy. Collaborate with world-class scientists and healthcare professionals to ensure studies meet FDA and GCP standards while advancing therapeutic breakthroughs. Enjoy a competitive benefits package, flexible work arrangements, and opportunities for professional growth in one of America's most vibrant healthcare hubs.
Responsibilities
- Oversee clinical trial protocols ensuring compliance with FDA regulations and Good Clinical Practice (GCP)
- Monitor investigational sites for protocol adherence and data integrity
- Manage study documentation, including case report forms (CRFs) and regulatory submissions
- Coordinate site visits, audits, and vendor relationships to maintain study timelines
- Analyze clinical data and prepare comprehensive study reports for stakeholders
- Mentor junior staff and contribute to process improvement initiatives
Qualifications
- Bachelor's degree in Life Sciences, Nursing, or related field (Master's preferred)
- 3+ years of clinical research experience with oncology trials
- Certified Clinical Research Professional (CCRP) certification required
- Proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Strong knowledge of FDA 21 CFR Part 312 and ICH-GCP guidelines
- Exceptional attention to detail and documentation skills
- Ability to travel up to 25% for site visits and conferences