Clinical Research Coordinator II

Position Summary

The candidate should be highly motivated, interested in pediatric diseases, have excellent interpersonal skills and an interest in academic research. We are looking for someone who can establish good rapport with children, adults and families as well as the clinical, research, and administrative teams. We emphasize the importance of team unity as central to our success.

The candidate will report to the Principal Investigator (PI), Dr. Chiriboga, and the research supervisor and will be responsible for subject recruitment and the conduct of clinical studies. Additional responsibilities include maintaining compliance with existing policies and procedures at Columbia University, the IRB, and the CTSA, that relate to clinical research.

Responsibilities

• Participation in pre-study, initiation, monitoring and close out visits
• Submission of FDA IND studies and PI initiated research protocols to other regulatory institutions in US
• Implementation of clinical trials from initiation, including assistance with the development of standard operating procedures and case report forms
• Recruitment and coordination of the clinical trial participants covering informed consent, screening, and inclusion of the subjects adhering to safety and compliance issues.
• Coordination and management of the clinical trial, communication with sponsor and monitors, visit coordination, sample acquisition and processing.
• Reporting and documentation of protocol deviations and exemptions as well as development and implementation of corrective action plans for review by the Principal Investigator as needed
• Data collection and management, collection of source documents, registration, and management of adverse events, filing and archiving, managing monitoring visits and managing queries.
• Close-out of the clinical trial, contributing to manuscripts, audit preparation, trial completion, and communication with authorities. Other responsibilities include assisting with the final study report and completing financial obligations.
• Other duties assigned as needed by the division.

Minimum Qualifications

• Bachelor's degree or equivalent in education and experience, plus three years of related experience

Other Requirements

• This is an on-site position