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.