Clinical Research Coordinator I

About the role

Columbia University Irving Medical Center (CUIMC) provides global leadership in scientific research, health and medical education, and patient care. The Clinical Research Coordinator (CRC) I supports the coordination of clinical research activities according to studies managed by the department.

Responsibilities

• Manages clinical trials (including some regulatory and budget requirements) and assists in the coordination of tests/visits for patients, working with the study team to maximize work efficiency to gather all required data and relevant clinical information.
• Reviews research protocols, assists Principal Investigators in study start up and submits studies to appropriate offices, interacts with the regulatory team to maintain regulatory documentation and administrative files for each protocol.
• Maintains procedures necessary for timely and complete data management and complies with required supervision tools such as work logs and regular meetings.
• Coordinates patient recruitment, screening, enrollment and follow-up with study participants, specimen processing, and other key protocol elements under direct supervision.
• Effectively communicates and maintains relationships with potential study subjects, participants, clinicians, other health care providers, sponsors, and research office staff to support the successful administration of clinical trials.
• Affords assistance with the coordination of research team meetings, investigator check-ins, Sponsor visits, external audits, and other stakeholder engagement activities.
• Supports research team members on various clinical trials or study related tasks.
• Ensures timely notification and/or communication between the Principal Investigator and compliance offices and study sponsors.
• Maintains 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.
• Possesses understanding and awareness of Corrective and Preventative Actions (CAPA).
• Coordinates 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.
• Adheres to workplace and patient safety protocols, monitors the area and ensures compliance with ethical and safety standards for research, and maintains research supply inventory, requesting additional items as needed.
• Coordinates patient enrollment, protocol treatment, and follow-up care for patients participating in clinical trials in conjunction with the clinical research nurse, research pharmacy, treatment center and other study staff.
• Communicates with various departments, physicians, labs, outside hospitals, and all members of the clinical team to ensure accuracy, timely retrieval of data, and confirm the appropriateness and timeliness of tests.
• Collects follow-up data on patients' post-treatment as required by the protocol and submits monthly reports to the clinical protocol office, tracking patient enrollment and accounts/payments for sponsored protocols.
• Completes timely research billing review, maintains and updates sponsor-related, university and department databases/logs, and represents Columbia University Irving Medical Center research as one of its frontline health research personnel.

Qualifications

• Bachelor’s degree or equivalent in education and/or experience.
• Two years of related experience or equivalent in education.
• Must possess critical thinking and analytical skills, customer-service orientation, with the ability to interact and collaborate positively, constructively and effectively with multiple stakeholders.
• Capacity to work semi-independently and successfully within a team in a deadline driven, multi-tasking environment.
• Strong oral and written communication skills.
• Strong commitment to fostering diversity and equity.
• Skilled with Microsoft Office, including strong Excel skills.
• Ability and willingness to learn new systems and programs.
• Bilingual (Spanish and English).
• At least 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.