Job Description
Join BioMed Solutions Inc., a leader in innovative pharmaceutical research, as our Senior Clinical Research Associate. Based in Boston's thriving biotech corridor, you'll lead pivotal clinical trials that shape the future of medicine. We offer a collaborative environment, cutting-edge resources, and opportunities to impact global healthcare outcomes. If you're passionate about scientific rigor and regulatory excellence, this role is your gateway to advancing life-changing therapies.
Responsibilities
- Design, execute, and monitor Phase I-III clinical trials across multiple therapeutic areas
- Ensure compliance with FDA regulations, ICH-GCP standards, and protocol requirements
- Manage site relationships, conduct site visits, and resolve operational challenges
- Analyze clinical data and prepare comprehensive study reports for regulatory submissions
- Collaborate with cross-functional teams including medical, regulatory, and biostatistics
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience with 2+ in CRA roles
- ICH-GCP certification and deep knowledge of FDA/EMA regulations
- Proven track record in oncology or rare disease trials
- Strong data management and medical writing skills
- Exceptional communication and problem-solving abilities
- Ability to travel 25-30% internationally