Patient Care and Clinical Research Coordinator

Overview
We are seeking a dedicated and highly organized Patient Care and Clinical Research Coordinator to join our dynamic healthcare research team. This role offers an exciting opportunity to contribute to cutting-edge clinical trials and patient care initiatives. The successful candidate will demonstrate a strong understanding of clinical research protocols, medical terminology, and patient monitoring, ensuring the integrity and compliance of all research activities. This position is integral to advancing medical knowledge while providing exceptional support to patients and research teams alike.

Duties

• Coordinate and manage clinical trials from initiation through completion, ensuring adherence to protocol, regulatory standards, and Good Clinical Practice (GCP) guidelines.
• Review and verify documentation for accuracy, completeness, and compliance with FDA regulations and ICH GCP standards.
• Monitor patient progress throughout the trial, including vital signs, blood sampling, and other clinical assessments while maintaining patient safety and comfort.
• Assist with patient recruitment, informed consent processes, and scheduling of study visits in accordance with ethical standards and HIPAA privacy regulations.
• Collect, manage, and analyze data using electronic medical record (EMR) systems, ensuring data integrity according to CDISC standards.
• Oversee clinical laboratory procedures such as blood sampling and phlebotomy, maintaining strict adherence to safety protocols.
• Supervise junior staff or research assistants in daily activities related to clinical trials management and data collection.
• Ensure compliance with all regulatory requirements, including FDA regulations, HIPAA privacy rules, and institutional policies related to clinical development.

Skills

• Proven experience supervising clinical research teams or staff involved in clinical trials management.
• Extensive knowledge of medical terminology, clinical laboratory procedures, and blood sampling techniques.
• Proficiency in using statistical software for data analysis relevant to research outcomes.
• Familiarity with EMR systems, data management tools, and adherence to CDISC standards for clinical data exchange.
• Strong understanding of FDA regulations, ICH GCP guidelines, and compliance management practices within clinical research settings.
• Experience with clinical development processes from trial design through data reporting phases.
• Certification in ICH GCP (from a recognized issuer) or equivalent is highly desirable; valid certification for California (CA) is preferred.
• Excellent analysis skills for interpreting complex datasets and ensuring high-quality documentation review.
• Knowledge of HIPAA regulations to maintain patient confidentiality throughout all phases of research activities. Join us in advancing healthcare through meticulous research coordination combined with compassionate patient care—making a meaningful impact on medical innovation while supporting the well-being of participants involved in vital clinical studies!

Job Type: Full-time

Pay: $25.00 - $55.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person