The Division of Developmental-Behavioral Pediatrics at Stanford University School of Medicine is seeking a highly organized, detail-oriented, and experienced Clinical Research Coordinator Associate to join our multi-site comparative effectiveness study. This landmark trial compares two medication treatments for Attention-Deficit/Hyperactivity Disorder (ADHD) in young children. The Clinical Research Coordinator Associate will be instrumental in executing the study protocol, ensuring compliance, and coordinating all aspects of participant recruitment, enrollment, and follow-up across our Stanford clinical site under close direction of the principal investigator.

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

DESIRED QUALIFICATIONS: Bachelor’s degree in a health-related field (e.g., Public Health, Nursing, Biology) or equivalent combination of experience and education. Prior experience as a clinical research coordinator or in a similar clinical research setting. Excellent communication, organizational, and time management skills. Familiarity with IRB requirements, FDA regulations, and Good Clinical Practice (GCP) guidelines. Fluency in Spanish (written and oral) is highly preferred to support recruitment goals for varied groups. Familiarity with REDCap is desirable.

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Clinical Research Coordinators (CRCs) support, conduct, coordinate or manage the clinical research studies or trials on human subjects. Principal and co-investigators provide the overall direction in a clinical study, but CRCs can have significant roles in clinical study activities.

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Drivers License Requirements

• Must possess and maintain a valid California non-commercial Class C Driver's License.

• Ability to drive day or night.

• When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.

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Core Duties:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through closeout.
• 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.
  

Minimum Education and Experience

Two-year college degree and two years related work experience or a bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.

Knowledge, Skills and Abilities:

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

Certificates and Licenses Required

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