Clinical Research Coordinator I

Clinical Research Coordinator I

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.

Responsibilities include, but are not limited to:

• 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 with ethical and safety standards for research, and maintain research supply inventory, requesting additional items as needed.
• Coordinates study 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.
• Working with the research nurse, treating physicians, and Principal Investigators to confirm that each patient meets eligibility criteria specified for protocols and enrollment into clinical trials.
• Communicating 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.
• Collecting follow-up data on patients' post-treatment as required by the protocol and submit 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
• Handling data management requirements for each patient enrolled.
• Abstracts, assembles, and organizes clinical research data.
• 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.
• Coordinator performs other related duties and participates in special projects as assigned.
• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Bachelor's degree or equivalent in education and/or experience.

Preferred Qualifications

• 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.

Equal Opportunity Employer / Disability / Veteran

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