• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $66,300.00 - $81,800.00

Position Summary

Columbia University Irving Medical Center (CUIMC) provides global leadership in scientific research, health and medical education, and patient care. Working in the Department of Radiology under the direction of the Assistant Director and assigned Principal Investigators (PI), the CRC II will support the coordination of clinical research activities according to clinical research studies or trials managed by the Department/Division.

The incumbent will serve as main contact for specific type/ area of research within the department and provide oversight and guidance for studies as assigned.

In general, the CRC II will be responsible for the coordination of patient participation (including screening, recruitment, assessment, and follow-up of study participants), collection and maintenance of study data, ensuring adherence to study activities as described in the protocol, and working with other members of the research team to coordinate all other aspects related to the conduct of the clinical trial or study.

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 some supervision.
• Effectively communicate, build and maintain relationships with potential study subjects, participants, clinicians, and other health care providers, and research office staff to support the successful administration of complex clinical trials.  
• Responsible for compliance of IRB protocols for assigned portfolio and serving as primary contact for assigned research areas. This may include but is not limited to review of documentation, eligibility and providing guidance for studies.
• Coordinate research team meetings, investigator check-ins, Sponsor visits, external audits and other stakeholder engagement activities.
• Ensures timely notification and/or communication between the Principal Investigator and compliance offices and study sponsors.
• Complete data entry activities with little supervision. 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, completing case report forms (CRFs), completing any study start-up or close-out documentation, and adverse event (AE) reporting.
• Prepare data reports and perform periodic auditing of data, certification, and reporting materials to ensure compliance with university, sponsor and federal policies.
• Provide input on Corrective and Preventative Actions (CAPA) under the oversight of the Principal Investigator (PI).
• Coordinate financial transactions related to the study including compensation to study subjects for their participation and helping them troubleshoot any issues.
• Support training and onboarding activities, including developing materials on protocol-specific items or clinical research procedures for their research team or peers.
• Adhere to workplace and patient safety protocols, monitor the area to ensure compliance with ethical and safety standards for research, and maintain and request additional supplies as needed. Use tools and reporting mechanisms to track progress, identify trends, and ensure timely communication of issues and status. 
• Represent Columbia University Irving Medical Center research as one of its frontline health research personnel and commit to using culturally appropriate communication methods.
• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Bachelor's degree or equivalent in education, training and experience

Preferred Qualifications

• Bi-lingual (Spanish and English)
• 3 years’ experience in a clinical research setting
• Master’s degree in a related field
• Familiarity with Columbia health and research systems.
• Education in a scientific, health-related, or business administration program or experience with observational research or laboratory settings
• Experience with electronic medical records and/or research data entry, including Epic, REDCap, Qualtrics, iLab, or OpenSpecimen.
• Understanding of clinical research systems and processes, Good Clinical Practice (GCP) guidelines, HIPAA, Columbia IRB and other institutional or federal regulatory and compliance activities.
• Familiarity with Regulatory and IRB submission processes

Other Requirements

• 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. Ability to handle multiple projects and apply judgment to prioritize projects and tasks.
• 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.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.