Job Summary
First Principles Research is looking for a Clinical Research Coordinators for our sites located in Pembroke Pines, North Miami Beach and Kendall, FL.
Two years of clinical research experience is required. This person will perform multiple trials each year and has to adapted to a fast pace and always changing environment. Duties include coordinating the clinical trials in compliance with all FDA protocols and specifications. Meet Standard Operating Procedures by contributing information to strategic plans and reviews.
Must be able to communicate in English and Spanish. CRC Certifications is a plus.
Duties
- Coordinate all aspects of clinical trial activities, including patient screening, enrollment, and monitoring to ensure adherence to study protocols and regulatory requirements.
- Review and verify clinical documentation, including consent forms, case report forms, and laboratory reports, maintaining accuracy and compliance with FDA regulations and ICH GCP standards.
- Monitor patient progress by tracking vital signs, blood sampling, and other clinical assessments while ensuring patient safety and comfort.
- Manage data collection processes using electronic medical record (EMR) systems and adhere to CDISC standards for data management and reporting.
- Conduct clinical laboratory procedures such as blood sampling and phlebotomy with precision, maintaining sterile techniques and safety protocols.
- Ensure all research activities align with healthcare compliance standards including HIPAA regulations, clinical ethical guidelines, and FDA requirements.
- Maintain thorough documentation review processes for accuracy, completeness, and regulatory compliance throughout the study lifecycle.
Qualifications
- Strong knowledge of clinical trials management, including regulatory frameworks such as FDA regulations, ICH GCP guidelines, and HIPAA compliance.
- Familiarity with medical terminology, clinical laboratory procedures (blood sampling, phlebotomy), and vital signs measurement.
- Certification in ICH GCP (Good Clinical Practice) from a recognized issuer is required; valid CA certification is preferred if applicable.
- Excellent analysis skills combined with meticulous attention to detail for documentation review and data accuracy.
- Strong project management skills with the ability to coordinate multiple tasks efficiently in a research environment.
- Knowledge of healthcare compliance regulations including HIPAA privacy rules is essential for safeguarding patient information.
Work Location: In person
