Clinical Research Coord I

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $70,000-$75,000

Position Summary

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

In general, the CRC 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 direct supervision.
• Responsible for compliance of IRB protocols for assigned portfolio under guidance of leadership and PI.
• Coordinate research imaging visits, including participant scheduling, MRI screening, scan-day logistics, protocol documentation, and communication with imaging facility staff and study investigators.
• Assist with organization and quality control of research imaging and clinical data, including tracking completeness of study datasets and identifying missing or unusable data for follow-up.
• Assist 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.
• 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.
• Ensures 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.
• Perform other related duties and responsibilities as assigned/requested

Minimum Qualifications

• Bachelor's degree or equivalent in education, training and experience.
• Must possess a 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 teams in a deadline driven, multi-tasking environment.
• Working knowledge of Microsoft Office, including strong Excel skills.

Preferred Qualifications

• Bi-lingual (Spanish and English)
• Some experience in a relevant clinical research field
• 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.

Equal Opportunity Employer / Disability / Veteran

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