Columbia University
Job Type: Officer of Administration
Regular/Temporary: Regular
Hours Per Week: 35
Salary Range: $64,350 - $65,000
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.
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 Binders and regulatory documents
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, plus a 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.
Required Skills/Abilities
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
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
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Regular/Temporary: Regular
Hours Per Week: 35
Salary Range: $64,350 - $65,000
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.
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 Binders and regulatory documents
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, plus a 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.
Required Skills/Abilities
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
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
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.