Job Description
Are you a detail-oriented professional passionate about accelerating drug discovery? GenVax Therapeutics is seeking a Senior Clinical Research Associate (CRA) to lead critical trials in our mission to deliver life-changing therapies. This is an opportunity to work within a dynamic, high-growth biotech environment where your expertise directly impacts patient health outcomes.
Why Join Us?
At GenVax, we pride ourselves on innovation and integrity. As a Senior CRA, you will be at the forefront of clinical operations, ensuring that our research meets the highest regulatory standards while maintaining the speed necessary to bring breakthrough treatments to market.
Responsibilities
- Oversee the execution of clinical trials from Phase I through Phase III, ensuring compliance with Good Clinical Practice (GCP) and internal Standard Operating Procedures (SOPs).
- Monitor trial sites remotely and on-site, conducting regular visits to assess site performance, data integrity, and patient safety.
- Collaborate with Cross-Functional Teams (CFTs) including Data Managers, Medical Writers, and Regulatory Affairs to resolve trial deviations and ensure timely reporting.
- Manage relationships with Contract Research Organizations (CROs) and Principal Investigators (PIs), acting as the primary liaison for trial-related inquiries.
- Prepare and submit clinical study reports, safety reports (DSURs), and regulatory submissions to health authorities.
- Identify potential risks and implement corrective and preventive actions (CAPA) to maintain trial quality and timelines.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field (Master’s degree or PharmD preferred).
- Minimum of 2-5 years of experience in clinical research, preferably within the pharmaceutical or biotechnology sector.
- Current certification as a Certified Clinical Research Professional (CCRP) or equivalent GCP certification.
- Deep understanding of FDA, EMA, and ICH guidelines regarding clinical trial conduct.
- Excellent interpersonal and communication skills, with the ability to influence and negotiate effectively with diverse stakeholders.
- Willingness to travel up to 50% of the time to various clinical sites across the US.