Clinical Research Coordinator
About this role
- Job Overview We are seeking a dedicated and detail-oriented Clinical Research Coordinator to join our dynamic research team.
- In this vital role, you will oversee the planning, execution, and management of clinical trials, ensuring compliance with regulatory standards and maintaining high-quality data collection.
- Your energetic approach will drive the success of research projects that aim to advance healthcare solutions.
- This position offers an exciting opportunity to be at the forefront of clinical development, working closely with healthcare professionals, patients, and regulatory bodies to bring innovative therapies from concept to reality.
- Responsibilities Coordinate all aspects of clinical trials, including participant recruitment, scheduling, and follow-up to ensure smooth project flow.
- Review and verify clinical documentation for accuracy, completeness, and compliance with FDA regulations and ICH GCP guidelines.
- Monitor patient safety and progress throughout the trial, ensuring adherence to ethical standards and healthcare compliance protocols.
- Manage data collection processes using electronic medical record (EMR) systems and ensure data integrity in accordance with CDISC standards.
- Supervise research staff and collaborate with multidisciplinary teams to facilitate project milestones and deliverables.
- Conduct clinical laboratory procedures such as blood sampling while maintaining strict adherence to clinical quality assurance standards.
- Prepare detailed reports, maintain comprehensive trial documentation, and review study protocols for consistency with regulatory requirements.
- Qualifications Proven supervising experience in a clinical research or healthcare setting.
- Strong knowledge of medical terminology, clinical research methods, and compliance management practices.
- Experience with clinical trials management systems, EMR platforms, and statistical software for data analysis.
- Certification in ICH GCP (Good Clinical Practice) from a recognized issuer; CA-specific certifications are a plus.
- Familiarity with FDA regulations, HIPAA privacy rules, and healthcare ethical guidelines.
- Demonstrated project management skills within a research environment; ability to coordinate multiple tasks efficiently.
- Clinical laboratory experience including blood sampling techniques; proficiency in data management and analysis skills.
- Excellent communication skills with the ability to review complex documentation accurately and thoroughly.
- Join us in advancing innovative healthcare solutions through meticulous research coordination!
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