Job Description
Join our pioneering team at BioTherapeutics Innovations, where cutting-edge science meets compassionate care. We're seeking a Senior Clinical Research Associate to drive transformative therapies through clinical trials. As a key player in our Clinical Operations division, you'll ensure adherence to GCP protocols while collaborating with cross-functional teams to accelerate life-changing treatments. Our Cambridge headquarters offers state-of-the-art labs and a dynamic environment where your expertise directly impacts patient outcomes.
Responsibilities
- Oversee clinical trial execution across 2-3 Phase II-III studies
- Conduct site monitoring visits and audit investigational sites
- Ensure protocol compliance and regulatory documentation accuracy
- Lead investigator meetings and training sessions
- Analyze clinical data and prepare regulatory submissions
- Manage study budgets and vendor relationships
- Mentor junior CRAs and implement process improvements
Qualifications
- BS/MS in Pharmacy, Life Sciences, or related field (PhD preferred)
- 5+ years clinical research monitoring experience in pharma/biotech
- Certified CRA (ACRP/SoCRA) required
- Deep knowledge of ICH-GCP and FDA regulations
- Experience with EDC systems (Medidata Rave, Oracle Inform)
- Therapeutic area expertise in oncology or rare diseases
- Exceptional problem-solving and stakeholder management skills
- Ability to travel 40-50% domestically