Job Description
Join BioMed Solutions Inc., a leader in innovative pharmaceutical therapies, as our Senior Clinical Research Associate. You will play a pivotal role in advancing groundbreaking treatments while ensuring compliance with global regulatory standards. This position offers the opportunity to lead critical clinical trials in our state-of-the-art Boston facility, collaborating with world-class researchers to bring life-changing therapies to market.
We offer a comprehensive benefits package including competitive compensation, flexible work arrangements, and continuous professional development opportunities. Be part of a team dedicated to improving patient outcomes through rigorous scientific excellence.
Responsibilities
- Design, monitor, and execute Phase I-IV clinical trials ensuring adherence to GCP, FDA, and ICH guidelines
- Lead site initiation, monitoring, and closeout activities across 8-10 global investigative sites
- Analyze clinical data integrity and implement corrective actions for protocol deviations
- Coordinate with CROs, regulatory agencies, and internal stakeholders to ensure trial timelines
- Mentor junior CRAs on regulatory requirements and risk-based monitoring strategies
- Prepare and maintain essential study documentation including IBs, SOPs, and regulatory submissions
Qualifications
- Master's degree in Life Sciences, Nursing, or Clinical Research with 5+ years' CRA experience
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Proven expertise in oncology or rare disease therapeutic areas
- Advanced proficiency in CTMS platforms (e.g., Medidata Rave, Veeva Vault RIM)
- Demonstrated success in managing complex, multi-site global trials
- Exceptional problem-solving skills with ability to troubleshoot protocol ambiguities
- Willingness to travel up to 30% domestically and internationally