Job Description
Join Boston Medical Innovations, a leader in cutting-edge clinical research, as we pioneer breakthrough treatments in oncology and rare diseases. We seek a meticulous Clinical Research Associate to ensure protocol compliance and data integrity across multi-center trials. This hybrid role offers competitive benefits, continuing education stipends, and opportunities to publish peer-reviewed research.
Responsibilities
- Monitor clinical trial sites for protocol adherence and regulatory compliance
- Conduct source data verification and audit clinical documentation
- Liaise with investigators and site coordinators to resolve protocol deviations
- Prepare and submit regulatory documents to FDA and IRB
- Analyze adverse event reports and ensure safety protocol execution
- Maintain electronic Case Report Forms (eCRFs) with 100% data accuracy
- Coordinate site initiation, monitoring visits, and close-out procedures
Qualifications
- Bachelor's degree in Life Sciences, Nursing, or related field
- CRA certification (ACRP or SOCRA) or equivalent experience
- Minimum 3 years clinical research monitoring experience
- Proficiency in EDC systems (Medidata Rave, Veeva Vault)
- Strong knowledge of ICH-GCP and 21 CFR regulations
- Exceptional attention to detail and problem-solving skills
- Ability to travel 40% of time domestically
- Experience with oncology or rare disease trials preferred