Overview
We are seeking a highly motivated and detail-oriented Senior Clinical Research Coordinator to join our dynamic research team. In this pivotal role, you will oversee the coordination and management of clinical trials, ensuring compliance with regulatory standards and maintaining the highest quality of data collection. Your expertise will drive the successful execution of research projects, support clinical development initiatives, and uphold rigorous ethical and safety standards. This position offers an exciting opportunity to contribute to groundbreaking healthcare research in a fast-paced, collaborative environment.
Duties
- Lead and supervise clinical research teams to ensure efficient trial operations and adherence to project timelines
- Coordinate all aspects of clinical trial activities, including patient recruitment, screening, enrollment, and follow-up monitoring
- Review and verify clinical documentation for accuracy, completeness, and compliance with FDA regulations, ICH GCP guidelines, and healthcare standards
- Oversee patient monitoring procedures such as vital signs, blood sampling, phlebotomy, and assessment of clinical endpoints
- Manage data collection processes utilizing EMR (Electronic Medical Records) systems and ensure data integrity according to CDISC standards
- Conduct regular site visits for quality assurance audits and ensure compliance with clinical ethical guidelines and healthcare regulations such as HIPAA
- Prepare detailed reports on trial progress, adverse events, and protocol deviations; assist in statistical analysis using specialized software tools
- Provide training and supervision to junior staff or research assistants on clinical research methods, documentation review, and regulatory requirements
- Maintain thorough knowledge of FDA regulations, ICH GCP guidelines, and clinical laboratory procedures to ensure ongoing compliance across all trials
- Support project management activities by coordinating schedules, tracking milestones, and facilitating communication among stakeholders
Qualifications
- Proven supervising experience within a clinical research setting or healthcare environment
- Strong understanding of medical terminology, clinical laboratory procedures, and healthcare compliance standards
- Experience with data management systems, EMR platforms, and statistical software used in clinical research analysis
- Knowledge of FDA regulations, ICH GCP guidelines, CDISC standards, and clinical ethical guidelines for research trials
- Demonstrated ability to review complex documentation accurately and efficiently
- Familiarity with project management principles in healthcare or research projects; certification in project management is a plus
- Clinical development experience including trial design, patient safety monitoring, and regulatory submissions
- Certification such as ICH GCP certificate from a recognized issuer (e.g., CA) is highly desirable
- Excellent organizational skills with attention to detail; ability to multitask in a fast-paced environment
- Strong communication skills to collaborate effectively with multidisciplinary teams including nurses, physicians, regulatory bodies, and sponsors
Join us in advancing healthcare through innovative research! We are committed to fostering a vibrant work environment that values your expertise while supporting your professional growth. This paid position offers an engaging opportunity to make meaningful contributions to clinical science while working alongside passionate professionals dedicated to improving patient outcomes.
Pay: $60,000.00 - $70,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Parental leave
- Vision insurance
Work Location: In person
