ADVANCE Biobank Clinical Research Coordinator

The Stanford Biobank within the Senior Associate Dean of Research Office at Stanford University’s School of Medicine is seeking a Clinical Research Coordinator to be the main support and lead for the ADVANCE Biobank. The ADVANCE Biobank is a philanthropically funded study to assemble a biorepository of specimens to investigate genetic differences in disease expression of Type 1 and 2 Diabetes and Monogenetic Diabetes among Asian subpopulations. This role has three main objectives on the biobanking side of the effort: cataloging and consolidating data and samples that already exist as a part of other Stanford lead biobanking efforts and other studies, prospective recruitment of new participants, and partnership with the Kaiser Research Biobank to identify participants with existing data and specimens to contribute to the study. This role will regularly interact with many investigators at Stanford to aid in the creation of this Biobank resource and be the main Biobank contact for requests to access samples for further study. There are no interventions associated with this study, so there is no FDA oversight. The incumbent will be responsible for reporting to study leadership and other key stakeholders on a regular basis on biobank progress and specimen availability and managing IRB submissions and renewals.

Duties include:
• 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.
• 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, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• 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.

* - Other duties may also be assigned