Clinical Research Coordinator Associate

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 a multi-site comparative effectiveness study of medication for attention deficit hyperactivity disorder (ADHD). This innovative landmark trial compares two medication strategies in children ages 6 to 16 years old - stimulant medications versus non-stimulant medications. The Clinical Research Coordinator Associate will be responsible for coordinating all aspects of participant recruitment, enrollment, and follow-up across our Stanford clinical site under close direction of the principal investigator and will be instrumental in executing the study protocol, ensuring strict compliance with all study protocols.

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 measures 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 or higher 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 in a similar clinical research setting and in clinical trials.
• 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.
• Experience with REDCap databases.

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.

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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.