Advertised Summary Job Description: The Division of Pediatric Cardiology in the Department of Pediatrics is seeking a Technician B to help assist on coordinating multiple clinical research studies. The work performed will support industry-funded trials that investigate cardiac catheterization interventions on children with congenital heart disease. The Tech B will report to the Division Administrator along with the PI of the studies.
Duties and Responsibilities 1. Assisting principal investigators and clinical research team in obtaining and updating all study requirements including IRB submissions, amendments and continuing reviews; reporting adverse events to the sponsor and IRB as needed. 2. Assisting investigators and research team with screening EMR for potential study participant eligibility, randomizing eligible patients, assisting with scheduling of study visits and tests, communicating with participants, and accompanying patients during visits. Assisting team with follow-up visit requirements as needed. 3. Assisting research team with study data collection and submission to databases and registries; collecting, processing, and shipping of protocol specimens, accompanying de-identified patient data, and/or documentation. 3. Upkeep of research patient study binders and files to ensure accuracy and proper documentation. This includes reaching out to outlying medical clinics and hospitals to obtain medical records, and collaborating with both CUMC ancillary sites and various hospital departments. Assisting research team with upkeep of electronic database as well. 4. Scheduling and being present for research monitor visits and FDA audits, if applicable.
Any other responsibilities as delegated by the research team or principal investigators.
General Minimum Qualifications: Requires a bachelor's degree in chemistry, biology, physics or related science or equivalent combination of education, training and experience.
Additional Specific Minimum Qualifications: -At least one year of experience working in clinical research. Knowledge/experience of clinical research compliance standards: informed consent process, adverse event reporting, HIPAA, Federal Code of Regulations, and Good Clinical Practice (GCP) standards. -Experience with research databases and data entry. -Organized with excellent attention to detail. -Conducts oneself in professional, timely manner. -Flexible and willing to learn. -Proficiency with Microsoft office suite: Word, Excel, Outlook, etc.
As a member of the National Collegiate Athletic Association (NCAA) and the Council of Ivy Group Presidents (Ivy League), it is imperative that members of the Columbia University community, in all matters related to the intercollegiate athletics program, exhibit the highest professional standards and ethical behavior with regard to adherence to NCAA, Conference, University, and Department of Intercollegiate Athletics and Physical Education rules and regulations.
Columbia University is an Equal Opportunity/Affirmative Action employer.
Internal Number: 126_168581
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