Job Description
Join MedTech Solutions Inc., a leader in innovative medical research, as a Senior Clinical Research Coordinator. You'll be pivotal in advancing groundbreaking treatments while ensuring compliance with FDA regulations and ethical standards. Collaborate with multidisciplinary teams to drive clinical trials from protocol development to final reporting in our state-of-the-art Boston facility.
Responsibilities
- Design and implement clinical trial protocols with principal investigators
- Monitor trial progress and ensure GCP compliance across multiple sites
- Manage electronic data capture systems and maintain regulatory documentation
- Liaise with IRBs and regulatory authorities for submissions and approvals
- Train clinical staff on trial procedures and safety protocols
- Analyze interim data and prepare FDA submissions
- Lead cross-functional teams to resolve protocol deviations
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- 5+ years of clinical trial coordination experience
- Certified Clinical Research Professional (CCRP) certification
- Expertise in FDA 21 CFR Part 11 compliance
- Proficiency in Medidata Rave and Oracle Clinical systems
- Strong knowledge of ICH-GCP guidelines
- Exceptional data management and audit trail documentation skills
- Experience leading multi-site oncology trials preferred