Job Overview
We are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our dynamic team. In this vital role, you will oversee the execution of clinical trials, ensuring compliance with regulatory standards and study protocols. Your energetic approach will drive the successful management of research projects, from site initiation through close-out, while maintaining the highest standards of quality and integrity. This position offers an exciting opportunity to contribute to groundbreaking medical research that can improve patient outcomes worldwide.
Responsibilities
- Monitor clinical trial sites to ensure adherence to study protocols, Good Clinical Practice (GCP), and regulatory requirements.
- Review and verify clinical documentation, including patient records, consent forms, and case report forms (CRFs).
- Conduct patient monitoring visits, including vital signs measurement, blood sampling, and phlebotomy procedures when necessary.
- Manage data collection and entry into electronic data management systems (EDC), ensuring accuracy and completeness.
- Ensure compliance with FDA regulations, ICH GCP guidelines, HIPAA privacy rules, and CDISC standards for data standardization.
- Supervise site staff and provide training on protocol procedures, documentation review, and regulatory compliance.
- Collaborate with clinical laboratories and EMR systems to facilitate specimen handling and data integration.
- Prepare detailed reports on trial progress, site performance, and adverse events for internal review and regulatory submission.
Skills
- Proven supervising experience in clinical trials management or related roles.
- Extensive knowledge of clinical development processes, including trial design, patient recruitment, and data management.
- Strong understanding of medical terminology, blood sampling techniques, vital signs assessment, and phlebotomy procedures.
- Familiarity with FDA regulations, ICH GCP guidelines, HIPAA compliance, and clinical laboratory operations.
- Proficiency in statistical software for data analysis and interpretation.
- Experience working with EMR systems and adhering to CDISC standards for data exchange.
- Excellent documentation review skills with meticulous attention to detail.
- Valid certification in ICH GCP (such as a GCP certificate from a recognized issuer) is required; additional certifications like a CA license or relevant nursing or research credentials are advantageous.
- Strong analysis skills combined with the ability to manage multiple projects efficiently in a fast-paced environment. Join us in advancing medical science through rigorous research practices! We are committed to fostering a vibrant work environment where your expertise makes a real difference in patients’ lives worldwide. All roles are paid positions dedicated to supporting your professional growth while contributing to innovative healthcare solutions.
Pay: $56,043.22 - $87,492.91 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: Hybrid remote in Princeton, NJ 08540
