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. The ideal candidate will have a strong desire to learn and grow rapidly, with a strong background in phlebotomy procedures and a certification as a Licensed Vocational Nurse (LVN).

The Clinical Research Coordinator will be responsible for coordinating and overseeing clinical research studies, ensuring compliance with regulatory requirements, and providing patient care within the framework of clinical trials. This role requires a strong ability to handle multiple tasks simultaneously and solve problems independently on a daily basis. The successful candidate will have a strong commitment to expanding access to clinical research in communities across the country.

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

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