Job Description
Join MedTech Innovations, a pioneer in cutting-edge medical research, as we revolutionize patient care through innovative clinical trials. We seek a Senior Clinical Research Coordinator to lead complex studies in our Boston facility. You'll collaborate with multidisciplinary teams to ensure protocol compliance, data integrity, and regulatory adherence while mentoring junior staff. Enjoy competitive benefits, flexible scheduling, and opportunities to publish groundbreaking research in top-tier medical journals.
Responsibilities
- Oversee end-to-end clinical trial management from protocol development to final report submission
- Ensure FDA/ICH GCP compliance and maintain meticulous regulatory documentation
- Coordinate site initiation, monitoring, and closeout activities across multiple trial sites
- Lead data management activities including CRF review, query resolution, and database lock
- Mentor junior coordinators and train new staff on SOPs and regulatory requirements
- Collaborate with biostatisticians on study design and statistical analysis plans
Qualifications
- Master's degree in Clinical Research, Nursing, or related health science field
- 5+ years of clinical trial coordination experience in therapeutic areas
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Proven expertise in FDA/ICH GCP regulations and clinical trial documentation
- Strong leadership skills with experience mentoring research teams
- Advanced proficiency in clinical trial management software (e.g., Medidata Rave)
- Exceptional attention to detail and ability to manage complex timelines