Job Description
Join BioPharm Innovations at the forefront of groundbreaking therapeutic development! We're seeking a Senior Clinical Research Associate to lead pivotal clinical trials in our Cambridge, MA headquarters. As a key player in our Clinical Operations team, you'll ensure compliance with FDA regulations, manage vendor relationships, and drive innovative research methodologies. Collaborate with cross-functional experts in a dynamic environment where your expertise directly impacts patient outcomes and drug approval timelines. Enjoy competitive benefits, flexible work arrangements, and opportunities for professional growth in one of biotech's most vibrant hubs.
Responsibilities
- Oversee clinical trial execution across multiple sites, ensuring adherence to GCP and protocol requirements
- Manage site monitoring, vendor relationships, and data quality assurance processes
- Lead safety reporting, regulatory submissions, and FDA communications
- Develop and maintain trial documentation, including CRFs, IBs, and informed consent forms
- Collaborate with Biostatistics, Medical Affairs, and Data Management teams
- 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 Phase II-III trials
- ICH-GCP certification and proven FDA regulatory knowledge
- Strong proficiency in eCRF systems (e.g., Medidata Rave) and EDC platforms
- Exceptional organizational skills with attention to detail and documentation
- Experience with oncology or rare disease trials highly desirable