Clinical Research Coordinator

3 days ago

San Jose, California, United States Topography Health Full time
About the Role

Topography Health is seeking a dedicated and experienced healthcare professional to join our research team as a Clinical Research Coordinator. As a certified LVN with a strong desire to learn and grow rapidly, you will have the opportunity to spearhead on-site efforts for our partner healthcare groups.

Key Responsibilities
  • Act as the study coordinator to execute trials conducted within physician practices, including visit preparation, follow-up activities, supply and inventory management, and third-party vendor management.
  • Coordinate and manage clinical research studies from initiation to completion, including patient recruitment, enrollment, and follow-up.
  • Conduct patient recruitment and enrollment of eligible patients, ensuring thorough screening and informed consent processes.
  • Lead patient study visits, which may include but are not limited to clinical and lab procedures such as ECG, phlebotomy, vital signs, body measurements, and laboratory processing.
  • Ensure protocol adherence and high data integrity, providing high-quality source data capture and documentation, including case report forms, source documents, and study logs.
  • Support study start-up and planning activities, including pre-study visits (PSVs), site initiation visits (SIVs), and IRB submission and correspondence.
  • Facilitate monitoring visits (IMVs) and sponsor correspondence, managing the follow-up process and ensuring compliance with regulatory requirements, institutional policies, and Good Clinical Practice (GCP) guidelines.
  • Manage the dispensation and accountability of investigational products, ensuring accurate tracking and documentation.
  • Monitor and document patient responses to treatments, managing adverse events, tracking, and follow-up as per protocol requirements.
  • Conduct data entry into case report forms/electronic data capture (CRF/EDC) systems and resolve queries in a timely manner.
  • Conduct Quality Control (QC) activities, including routine checks during and following study visits to ensure meticulous accuracy in documentation.
  • Provide training and support to research staff, mentoring junior research staff, and ensuring adherence to study protocols and standard operating procedures (SOPs).
  • Participate in the development and implementation of study protocols and quality assurance processes, utilizing and improving Topography's proprietary tool set.
  • Assist in the preparation for audits and inspections by regulatory agencies, supporting study close-out activities (COVs), and managing protocol deviation tracking, reporting, and reconciliation.
Minimum Qualifications
  • Certified LVN
  • 1+ years of experience with phlebotomy procedures
  • Fluent in Vietnamese
Preferred Qualifications
  • Previous research experience

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