Clinical Research Coordinator Associate, Stanford Child Wellness Lab

The Department of Pediatrics – Division of Critical Care Medicine is seeking a Clinical Research Coordinator Associate to conduct clinical research in the Stanford Child Wellness Laboratory.  Studies include enrollment of healthy and critically ill children, interaction with community agencies as well as clinical staff at Lucile Packard Children’s Hospital.

Duties include*:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through closeout.  Help P.I. with study set up and IRB approval process. Prepare draft budget.
• Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies. Screen patients for clinical studies, determine eligibility, obtain consent from families and assess enrollment targets.
• Coordinate collection of study specimens and processing.  Collect biospecimens using appropriate safety measures; ensure accurate labeling and sample 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. Assure quality data collection using paper and online Case Report Forms, digital image data, and other data sources. Train and supervise other research assistants and assistant coordinators as funding increases.
• 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.  Review and audit data collection and submissions according to IRB approved protocols. Respond to IRB queries in a timely manner, complete the Continuing Review requirements annually.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.  Also assist in developing the REDCAP database for ongoing studies, as well as collect, enter and query data into the REDCAP database.
• 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.  Meet with P.I. and Lab Manager weekly to provide ongoing updates. Tabulate data on study performance.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.  Responsible for understanding and adhering to compliance regulations from IRB, FDA, Sponsor, etc.  Participate in monitor visits and regulatory audits.
• Explore and report on additional sites for collaboration and data collection.  Meet with Clinics Managers, Administrators of Day Care Centers, or Santa Clara County staff to examine other sites for data collection.
• Help with grant applications to NIH and other funding agencies. Prepare grant submission forms, collate materials for Appendix, check budget for accuracy, and develop figures.

* - Other duties may also be assigned

~ All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels. ~