The Columbia University Division of Infectious Diseases is seeking a highly motivated individual to provide programmatic support and administrative coordination for COVID-19 research and implementation studies. Trials may include inpatient or outpatient investigation of novel therapeutics, vaccines, monoclonal antibodies, and observational cohorts, among others.
Assess, design, and evaluate research protocol requirements for study implementation.
Develop and maintain research procedures with the goal of standardization, increase efficiency and ensure compliance with all guidelines, protocols and federal regulations.
Conduct and document quality assurance reviews.
Assist in both the development and completion of case report forms in accordance with study protocol requirements and collaborate with the research team in developing and implementing data collection tools and quality management plans.
Oversee the development and maintenance of SOPâ€™s and office policies, make recommendations to improve organizational operations.
Assure careful compliance with Institutional Review Board (IRB) standards and policies in all study activities.
Identify and contact prospective study participants and obtain informed consent.
Perform required screening and on-going study evaluations.
Explain research protocols and obtain informed consent from study participants when appropriate.
Assist the team with community engagement activities.
Maintain repository of specimens, log of specimens shipped to central labs and quality control of database.
Perform additional related duties as needed.
Bachelor's degree or equivalent in education and experience, plus four years of experience
Attention to detail with ability to manage time effectively
Strong organizational, clinical and decision-making skills
Knowledge of a variety of computer and software applications [Microsoft office, REDCap, electronic data entry systems i.e. Medidata]
Ability to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
Ability to handle confidential information and maintain confidentiality in accordance to HIPAA
Infectious disease clinical and/or research experience
Prior experience with phlebotomy
Experience working with diverse and marginalized populations
Fluency in Spanish
Participation in the medical surveillance program
Contact with patients and/or human research subjects
Wear N-95 respirator
Potential bloodborne pathogen exposure
Successful completion of applicable compliance and system training requirements
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 508744
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.