# Advertised Summary Job Description
The Clinical Research Coordinator / QA Monitor will work under the direct supervision of the Vice Chair and the Director of Research Administration and various Principal Investigators in the Department of Pediatrics. S/he will be responsible for IRB protocol submission, identifying and screening eligible subjects, and the initiation and conduct of pediatric clinical research studies, including sample collection and coordinating the pediatric medical registry. The CRC will maintain detailed study files and complete paper and electronic case report forms, ensure data quality, integrity and compliance with all regulatory, institutional, and departmental requirements. The ability to be flexible with scheduling is critical.
Additionally, the candidate will be responsible for the oversight and quality assurance activities of investigator-initiated FDA IND/IDE and industry and NIH sponsored studies within the Department of Pediatrics. This position requires a motivated individual with excellent interpersonal skills and strong organizational qualities who can interact with investigators, researchers and research staff members within the Department of Pediatrics and throughout Columbia University. This individual must have knowledge of the process of conducting pediatric clinical research. While working under the direct supervision of the Pediatrics Vice Chair and the Director of Research Administration, the incumbent should be self directed and capable of working independently. In addition, the Quality Assurance Monitor will be responsible for monitoring and enforcing standardization of the research process. The incumbent will assist with research regulatory procedures including Institutional Review Board submissions for various research studies. The incumbent may interact with human subjects and provide staff coverage as needed.
The ideal candidate will be responsible for:
?Performing chart reviews on randomly selected charts
?Performing focused chart reviews on high volume enrollment studies or complex procedures
?Performing data Forms Audits
?Performing source Documentation reviews
?Collecting outcome data collection as needed
?Reviewing records of patients with queries, edits and audits identified as being problematic
?Monitoring data management procedures and make recommendations for improvement
?Developing tools for standardized research documentation
?Serving as a research liaison between the department and the divisions
?Developing materials for dissemination to staff and faculty when new protocols are implemented
?Providing education to research staff members related to study protocol and research activity within the department
?Developing tools for personnel training and orientation
?Participating in divisional and department research education meetings
?Monitoring compliance with all HIPPA, GCP, billing, safety and other research specific regulations / guidelines
?Other related duties as assigned.
# Minimum Qualifications for Grade Applicant meet these minimum qualifications to be considered an applicant
Requires a bachelor''s degree or equivalent in education and experience, plus four years of related experience.
# Additional Position-Specific Minimum Qualifications Applicant meet these minimum qualifications to be considered an applicant
Knowledge of FDA IND/IDE processes. Excellent verbal and written communication skills and extraordinary attention to detail.
Must possess knowledge of Microsoft Office such as excel, word, powerpoint, etc., and experience with web database entry.
# Preferred Qualifications
Ability to speak Spanish is desirable, five years of experience in sponsored research.
# Special Instructions
# Special Indications This position works with:
Bloodborne pathogens
Contact with patients and/or research subjects
*Job Title:* Clinical Research Coordinator/QA Monitor
*Job Requisition Number:* 073855
*Department:* 7540- PED Pediatrics
*Location:* Medical Center
*Job Type:* Officer Full-Time Regular
*Hours Per Week:* 35
*Job Family:* General Administration
*Salary Grade:* Officer 105
*Salary Range:* Commensurate with experience
*HIPAA Compliance training required:* Yes
*Participation in Medical Surveillance required:* Yes
*What type of posting? Is this a waiver request?:* Standard Posting
*Requisition Open Date:* 05-27-2014
*Requisition Close Date:* Open Until Filled
*Quick Link:* jobs.columbia.edu/applicants/Central?quickFind=142100
*EEO Statement:* Columbia University is an Equal Opportunity/Affirmative Action employer --Race/Gender/Disability/Veteran.
*Local Hiring:* Columbia University is committed to the hiring of qualified local residents.