Clinical Research Coordinator I

Grade 103

• 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 - $68,000

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Columbia University Irving Medical Center (CUIMC) provides global leadership in scientific research, health and medical education, and patient care. Working in the Clinical Protocol & Data Management office in the Herbert Irving Comprehensive Cancer Center under the direct supervision of the Clinical Research Manager (CRM) or the specific disease site this incumbent is assigned to, the Clinical Research Coordinator (CRC) I will support the coordination of clinical research activities according to clinical research studies or trials managed by the department.

In general, the CRC I 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.

This position is primarily based out of the Herbert Irving Pavilion, 161 Fort Washington Avenue, Mezzanine level, New York, NY. Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.

The CRC I 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.

• Reviewing research protocols.
• Assisting Principal Investigators in study start up and submitting studies to appropriate offices.
• Interacting with the regulatory team to maintain regulatory documentation and administrative files for each protocol.
• Under the supervision of the clinical research manager, the coordinator maintains procedures necessary for timely and complete data management and complies with required supervision tools such as work logs and regular meetings. The coordinator will also comply with necessary regulatory responsibilities as needed.
• 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.
• 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.
• Ensures timely notification and/or communication between the Principal Investigator and compliance offices and study sponsors.
• 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…