• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $66,300.00 - $66,300.00

Position Summary

The Research Division of the Department of Emergency Medicine is seeking a Clinical Research Coordinator to lead clinical studies being conducted in the Pediatric Emergency Department.

Reporting to the Research Manager and under supervision of the department?s Principal Investigators (PI), the Clinical Research Coordinator will support the department?s research portfolio by organizing and conducting all aspects of clinical research projects as a member of the Research Coordinator team. This role will involve a variety of responsibilities, including coordination of patient participation (i.e. recruitment, screening, enrollment, and follow-up), collection and maintenance of study data, management of regulatory materials, and ensuring adherence to study protocol activities in accordance with clinical research principles.

Responsibilities

General Study Management:

• Organization of the start-up of studies, including preparation and submission of protocols to the IRB and training of study personnel.
• Maintenance and organization of project documentation and records, and preparation and submission of protocol renewals.
• Maintenance of essential documents and regulatory binders.
• Organization of study meetings and study-related administrative processes.
• Ensuring compliance with the University's required certifications in Human Research Protection and HIPAA regulations.
• Communicating with all members of research team, various collaborating departments, and clinical staff to ensure success of studies.

Patient Management

• Patient enrollment, including obtaining informed consent.
• Working with treating physicians and Principal Investigators to confirm that each patient meets eligibility criteria specified for protocols.
• Conferring with study patients to explain the purpose of the research study and diagnostic procedures.
• Completion of patient follow-up, as appropriate.

Data Management:

• Collection of pertinent information and data from subject charts and records, subject interviews, and other sources to meet data entry deadlines as outlined in protocols.
• Completion of case report forms (CRFs), including review of CRFs to ensure completeness.

Other:

• Performance of Quality Assurance/Quality Control tasks.
• Some evening and weekend shifts may be required.
• Other related duties as necessary.
• Position is supported by grant funding.

Minimum Qualifications

• Requires a bachelor's degree or equivalent in education and experience.
• Strong organizational skills and attention to detail.
• Excellent written and oral communication skills.
• Demonstrates good judgement under pressure.
• Ability and willingness to learn new systems and programs.
• Ability to undertake multiple tasks simultaneously and prioritize responsibilities.
• Must be motivated and proactive.
• Capacity to work both independently and perform as part of a team.
• Proficient in Microsoft Office and web browser programs.

Preferred Qualifications

• Minimum of two years of related experience in clinical research or a health science discipline, such as biochemistry, anatomy, pathology, nursing, medical technology, public health, or equivalent.
• Experience in clinical research setting with knowledge of HIPAA and GCP
• Prior involvement in the coordination and implementation of research projects
• Experience with IRB
• Experience with electronic medical records and/or research data entry, including Epic, REDCap, Qualtrics, or OpenSpecimen
• Fluency in Spanish

Other Requirements

• Direct patient contact and/or interaction with human research subjects.
• Use of N-95 respirator as needed.
• Successful completion of all required compliance and systems training.

Equal Opportunity Employer / Disability / Veteran

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

About Columbia University

Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.

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