Summary

The Clinical Research Associate is responsible for the data management activities of moderate to complex clinical trials and research protocols for the Department of Pediatrics, Research Resource Office (RRO). Primary responsibilities include project management and data reporting of research patient data. Will also contribute to research protocol budget developments, cost assessments, and study reconciliations.

Job Duties

• Independently manages the daily operations of moderate to complex clinical trials and research protocols.
• Independently manages database of pending and prior clinical trials and research protocols. 
• Provides guidance to investigators and other research staff, and serves as an source of expertise for data management projects, concepts and approaches.
• Conducts research subject recruitment, screening, and enrollment. Participates in subject consent process.
• Develops and maintains manual of operations, sop's, and procedural guides/guidelines. 
• Provides budget input and guidance to investigators and other research staff, helping to develop cost assessments, draft budget justifications and complete other budget forms for submission and reporting.
• Completes data reporting in accordance with good clinical practice, federal regulations and institutional policies: 
  • Oversees regulatory activities, including quality assurance and safety programs.
  • Develops management plans to ensure timeliness and accuracy in data entries and reporting.
  • Oversees submission of serious adverse event reporting and follow-up as needed.
• Assists with expense oversight and study reconciliations.
• Performs other job-related duties as assigned.
   

Minimum Qualifications

• Bachelor's degree.
• Two years of relevant experience.

Preferred Qualifications

• Prior experience working in an academic research setting strongly preferred.
• Ability to understand and manage the complexities of clinical trials and research protocols, including issues related to informed consent, access to data, and conflict of interest. 
• Strong attention to detail and data quality.