Clinical Research Coordinator

Overview
Join our dynamic team as a Clinical Research Coordinator and be at the forefront of advancing medical science through meticulous clinical trials. In this vital role, you will oversee the planning, execution, and management of clinical research studies, ensuring adherence to regulatory standards and protocol requirements. Your energetic approach will drive the success of research projects that aim to improve patient outcomes and contribute to groundbreaking medical discoveries. This paid position offers an exciting opportunity to develop your expertise in clinical development within a collaborative and innovative environment.

Duties

• Coordinate all aspects of clinical trials, including participant recruitment, screening, enrollment, and follow-up care.
• Manage trial documentation by reviewing case report forms, consent forms, and regulatory documents for accuracy and compliance with FDA regulations and ICH GCP standards.
• Monitor patient progress by recording vital signs, blood sampling, and other clinical assessments while ensuring patient safety and comfort.
• Oversee data collection and management using electronic medical record (EMR) systems and ensure data integrity in accordance with CDISC standards.
• Conduct patient monitoring visits, review laboratory results, and ensure timely reporting of adverse events or protocol deviations.
• Supervise research staff and coordinate training on clinical trial procedures, regulatory compliance, and documentation review.
• Maintain compliance with HIPAA regulations to protect patient confidentiality throughout all research activities.
• Prepare for audits by regulatory agencies by maintaining detailed records of trial activities, data management processes, and adherence to FDA guidelines.
• Collaborate with clinical laboratories for blood sampling procedures and ensure proper handling of specimens according to protocol.
• Stay current with clinical trials management practices, FDA regulations, ICH GCP certification requirements, and emerging trends in clinical development.

Skills

• Proven supervising experience in a clinical research setting or related healthcare environment.
• Extensive knowledge of clinical trials management processes from initiation through closeout phases.
• Strong understanding of medical terminology, blood sampling techniques, vital signs measurement, and phlebotomy procedures.
• Proficiency in reviewing complex documentation including informed consent forms, regulatory submissions, and laboratory reports.
• Experience with data collection tools, statistical software, EMR systems, and data management platforms aligned with CDISC standards.
• Familiarity with FDA regulations governing clinical trials as well as HIPAA privacy rules to ensure compliance at all times.
• Background in nursing or clinical laboratory work is highly desirable for comprehensive patient monitoring responsibilities.
• Ability to analyze clinical data accurately using analysis skills to identify trends or issues within trial results.
• Certification in ICH GCP (Good Clinical Practice) from a recognized issuer for California or equivalent is required to ensure ethical conduct of research studies.
• Strong organizational skills with the ability to supervise staff effectively while managing multiple projects simultaneously.
• Excellent communication skills for collaborating across multidisciplinary teams including investigators, sponsors, laboratories, and regulatory bodies. Embark on a rewarding career that makes a real difference! We are committed to fostering an inclusive environment where your expertise can thrive while contributing to innovative health solutions that impact lives worldwide.

Job Type: Full-time

Pay: $25.00 - $35.00 per hour

Work Location: In person