Job Overview
We are seeking a dynamic and detail-oriented Clinical Research Coordinator to join our innovative research team. In this vital role, you will oversee the execution of clinical trials and research projects, ensuring compliance with regulatory standards and ethical guidelines. Your energetic approach will drive the successful collection of data, monitoring of patient safety, and coordination of research activities across multiple projects. This position offers an exciting opportunity to contribute to groundbreaking medical advancements while working in a collaborative, fast-paced environment that values your expertise and dedication.
Duties
- Coordinate all aspects of clinical trials, including participant recruitment, screening, enrollment, and follow-up
- Monitor patient progress and ensure adherence to study protocols while maintaining high standards of patient safety and comfort
- Review and verify clinical documentation for accuracy, completeness, and regulatory compliance
- Manage data collection processes using electronic medical record (EMR) systems and adhere to CDISC standards for data management
- Ensure compliance with FDA regulations, ICH GCP guidelines, and healthcare industry standards throughout all research activities
- Supervise research staff and collaborate with multidisciplinary teams to facilitate project milestones and deliverables
- Conduct clinical laboratory procedures such as blood sampling and sample processing in accordance with protocol specifications
- Prepare reports, maintain detailed records, and review documentation for quality assurance purposes
- Utilize statistical software to analyze research data and support findings for publication or regulatory submission
- Maintain up-to-date knowledge of clinical development processes, ethical guidelines, and regulatory changes impacting clinical trials
Requirements
- Proven supervising experience in a clinical research or healthcare setting with strong leadership skills
- In-depth knowledge of medical terminology, clinical research methods, and healthcare compliance standards
- Experience reviewing complex documentation such as informed consent forms, case report forms (CRFs), and regulatory submissions
- Ability to monitor patients effectively during clinical trials while ensuring adherence to protocols
- Proficiency with statistical software packages used in clinical data analysis
- Familiarity with FDA regulations, ICH GCP guidelines, CDISC standards, and clinical quality assurance standards
- Hands-on experience with clinical laboratory procedures including blood sampling and sample handling
- Strong project management skills within a research environment; experience managing multiple studies simultaneously
- Knowledge of EMR systems for efficient data entry and retrieval; proficiency in Microsoft Office suite for documentation purposes
- Certification in ICH GCP from a recognized issuer (e.g., CA) is required; additional certifications in healthcare compliance or project management are advantageous
- Excellent analytical skills coupled with meticulous attention to detail to ensure high-quality research outcomes
Join us in advancing medical science by coordinating impactful clinical trials that improve patient lives worldwide. Your expertise will help shape the future of healthcare through rigorous research practices aligned with the highest ethical standards.
Pay: $30.00 - $75.00 per hour
Benefits:
- Flexible schedule
- Professional development assistance
- Tuition reimbursement
Work Location: Hybrid remote in San Diego, CA 92104
