Clinical Research Coordinator II

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 20
• Standard Work Schedule:
• Building:
• Salary Range: $41,142 - $41,142

Position Summary

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) II will support the coordination of clinical research activities according to clinical research studies or trials managed by the department.

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.

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

The CRC II manages clinical trials (including some regulatory and budget requirements) and assists inthe coordination of tests/visits for patients, working with the study team to maximize work efficiency
to gather all required data and relevant clinical information.

Responsibilities include, but are not limited to:

GENERAL STUDY MANAGEMENT

• 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 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 clinical trials.
• 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.
• 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.
• 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 activities and 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.

PATIENT MANAGEMENT

• 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
• Represent Columbia University Irving Medical Center research as one of its frontline health research personnel and commit to using culturally appropriate communication methods.

DATA MANAGEMENT

• Handling data management requirements for each patient enrolled.
• Abstracts, assembles, and organizes clinical research data.
• Prepare data reports and perform periodic auditing of data, certification, and reporting materials to ensure compliance with university, sponsor and federal policies.
• Complete data entry activities with little supervision. Data entry may include Protected Health Information (PHI), clinical and billing or other administrative data

OTHER

• Coordinator performs other related duties and participates in special projects as assigned.
• Completes or contributes to a department wide process improvement project or initiative.
• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Bachelor's degree or equivalent in education, training, and experience in a relevant clinical
  research field.
• Minimum of one year as a Clinical Research Coordinator I or equivalent in oncology.

Preferred Qualifications

• Two years of related experience or equivalent in education.
• Meets or exceeds expectations on annual review (if applicable).
• 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, multitasking 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.

Other Requirements

• Bilingual (Spanish and English).
• Three years experience in a clinical research setting.
• 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.

Equal Opportunity Employer / Disability / Veteran

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