Clinical Research Coordinator Associate

The Clinical Research Coordinator Associate is responsible forthe overall implementation of an assigned set of research protocols assuringefficiency and regulatory compliance. These studies will be conducted at the StanfordHospital and Clinics. The CRCA will workas part of a clinical trials research team and report to the Clinical ResearchManager and various Principal Investigators conducting clinical research withinthe Stanford Stroke Center. Responsibilitiesinclude recruit, screen, assist in the informed consent process and enrollsubjects in accordance with good clinical practice guidelines; collect, recordand maintain complete data files using good clinical practice in accordance withHIPAA regulations. He/she participates in data retrieval, reporting, andpreparation of files and Case Report Forms for the various studies. The successful candidate will interact withsubjects by scheduling diagnostic and research evaluation visits, perform studyrelated assessments including neuropsychological testing, collection and processingof blood samples. Maintain drugaccountability, adequate study supplies and equipment. The coordinator willoversee subject compliance to the study protocol, obtain information from thestudy subject regarding any changes in their medications or adverse events andpromptly report the findings to physicians for documentation in the subject’smedical record. Report all serious adverse events promptly to investigators,sponsors and the IRB. Protect the rights, safety and well-being of humansubjects involved in the clinical trials.

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
• Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing and shipping.
• Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.
• Assemble study kits for study visits, prepare study documents for data collection.
• Attend monitoring meetings with sponsors as needed, acting as primary contact.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.