Clinical Research Coord I

Responsibilities

• Responsible for day-to-day aspects of study protocol tasks including participant recruitment, screening, enrollment and follow-up with study participants, specimen processing, and other key protocol elements under direct supervision.
• Effectively communicate and maintain relationships with potential study subjects, participants, clinicians, other health care providers, sponsors, and research office staff to support the successful administration of clinical trials.
• Aid in the coordination of research team meetings, investigator check-ins, Sponsor visits, external audits, and other stakeholder engagement activities.
• Support research team members on various clinical trials or study related tasks.
• Ensure timely notification and/or communication between the Principal Investigator and compliance offices and study sponsors.
• Complete data entry activities with supervision and support as needed. Data entry may include Protected Health Information (PHI), clinical and billing or other administrative data.
• Maintain accurate and complete clinical research files which may include administering questionnaires, assisting preparation and completion of case report forms (CRFs), and completing any study start-up or close-out documentation, and adverse event (AE) reporting.
• Possess understanding and awareness of Corrective and Preventative Actions (CAPA).
• Coordinate financial transactions related to the study, including but not limited to compensation to study subjects for their participation and helping them to troubleshoot any issues.
• Adhere to workplace and patient safety protocols, monitor the area, and ensure compliance with ethical and safety standards for research, and maintain research supply inventory, requesting additional items as needed.
• Represent Columbia University Irving Medical Center research as one of its frontline health research personnel and commit to using culturally appropriate communication methods.

Qualifications

• Bachelor's degree or equivalent in education, training and experience.
• Bi-lingual (Spanish and English) preferred.
• 2 years of experience in a relevant clinical research field.
• Familiarity with Columbia health and research systems.
• Education in a scientific, health-related, or business administration program or experience with observational research or in laboratory settings.
• Experience with electronic medical records and/or research data entry, including Epic, REDCap, Qualtrics, iLab, or OpenSpecimen.
• Knowledge of clinical research systems and processes, Good Clinical Practice (GCP) guidelines, HIPAA, Columbia IRB and other institutional or federal regulatory and compliance activities.