Job Description
We are seeking a detail-oriented and driven Senior Clinical Research Associate (CRA) to join our dynamic team in Boston. At BioGenius Innovations, we are at the forefront of developing breakthrough therapies that change lives. You will play a pivotal role in the clinical trial process, ensuring data integrity, patient safety, and regulatory compliance across our global portfolio.
Why Join Us?
- Competitive salary and comprehensive benefits package.
- Opportunity to work on cutting-edge therapeutic areas.
- Commitment to professional development and career growth.
If you are passionate about healthcare and have a strong background in clinical operations, we want to hear from you.
Responsibilities
- Conduct on-site monitoring visits to clinical trial sites to ensure protocol compliance and data accuracy.
- Monitor trial progress, timelines, and budgets to identify risks and implement mitigation strategies.
- Review and verify source documentation to maintain Good Clinical Practice (GCP) standards.
- Liaise effectively with site investigators, study coordinators, and internal cross-functional teams.
- Prepare and submit clinical trial reports, amendments, and deviation reports in a timely manner.
- Manage complex relationships with external vendors and regulatory bodies.
Qualifications
- BS/MS in Pharmacy, Nursing, Life Sciences, or a related field.
- Minimum of 3-5 years of experience as a CRA in the pharmaceutical or biotechnology industry.
- Valid Driver's License and willingness to travel (up to 50% of the time).
- Strong working knowledge of ICH-GCP guidelines and regulatory requirements.
- Excellent communication, interpersonal, and problem-solving skills.
- Proficiency in electronic data capture (EDC) systems (e.g., Oracle Clinical, Rave).