The Division of Neonatal & Developmental Medicine in the Department of Pediatrics is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of clinical studies for two research groups within the Division: The Safety Learning Lab and the California Perinatal Quality Care Collaborative (CPQCC). The Safety Learning Lab for Neonatal and Maternal Care is federally-funded by the Agency for Research and Quality and is dedicated to improving patient safety for mothers and babies during labor and delivery. We use a mixed methods approach to develop, pilot, and test various aspects of maternal and neonatal care. Our team is comprised of parent stakeholders, healthcare providers, and experts in design and human factors. CPQCC is a consortium of more than 130 NICUs across California that contribute data to the data center based at Stanford. We coordinate research protocols with collaborators across the country using this data and also conduct quality improvement activities across the state. The Clinical Research Coordinator will work under close direction of the principal investigator and/or study coordinator/supervisor.
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.
• 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.
• Perform qualitative data analysis and standard quantitative analysis of interview and survey data. Summarize data in manuscript and presentations to the study team.
• Assist with writing and formatting the data, methods, tables and reference sections of the manuscripts and presentations.

* - Other duties may also be assigned

DESIRED QUALIFICATIONS:

• Demonstrated interest in maternal and child health.
• Experience with research coordination.
• Ability to work independently and follow protocols when necessary.
• Ability to collaborate with stakeholders from various disciplines and research subjects.
• Strong written and oral communication skills.

EDUCATION & EXPERIENCE (REQUIRED):

• Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:

• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

PHYSICAL REQUIREMENTS*:

• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
• Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
WORKING CONDITIONS:

• Occasional evening and weekend hours.

Additional Information

• Schedule: Full-time
• Employee Status: Regular
• Grade: F
• Department URL: http://pediatrics.stanford.edu/