Job Description
Join MedSolutions Group at the forefront of medical innovation! We're seeking a Senior Clinical Research Coordinator to lead groundbreaking studies in oncology therapeutics. This role combines rigorous scientific methodology with compassionate patient care in our state-of-the-art Boston research facility.
What you'll achieve:
- Design and execute multi-phase clinical trials
- Collaborate with FDA, IRB, and global research partners
- Drive protocol development and regulatory compliance
- Mentor junior research staff
- Present findings at industry conferences
Competitive benefits include 401(k) matching, continuing education stipends, and comprehensive health coverage.
Responsibilities
- Oversee all phases of clinical trial execution from protocol design to final report
- Manage relationships with investigative sites and principal investigators
- Ensure strict adherence to GCP and HIPAA regulations
- Analyze complex biomedical data using SAS and R
- Lead site initiation visits and monitoring activities
- Prepare regulatory submissions and maintain study documentation
- Collaborate with biostatisticians on protocol amendments
- Represent company at FDA audits and inspections
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- 5+ years clinical trial coordination experience in oncology
- Certified Clinical Research Professional (CCRP) required
- Advanced proficiency in EDC systems (e.g., Medidata Rave)
- Demonstrated success in FDA-regulated studies
- Strong knowledge of ICH-GCP guidelines
- Experience with oncology therapeutic areas (chemotherapy/immunotherapy)
- Exceptional project management and communication skills