Columbia University Clinical Research Manager - Infectious Diseases in New York, New York
Requisition no: 508742
Work Type: Full Time
Location: Campus|Medical Center
Job Type: Officer of Administration
Bargaining Unit: n/a
End Date if Temporary: n/a
Hours Per Week: 35
Salary Range: Commensurate with experience
The Columbia University Division of Infectious Diseases is seeking a highly motivated Registered Nurse or Advanced Practice Clinician (NP or PA) to provide clinical investigator support, administrative coordination and care for COVID-19 clinical trials. Trials may include investigation of novel therapeutics, vaccines, monoclonal antibodies, and observational cohorts, among others.
Identify and contact prospective study participants and obtain informed consent.
Perform required screening and on-going study evaluations.
Determine eligibility of screened study participants through physical exam, medical history, laboratory results and other research procedures.
Perform phlebotomy and peripheral intravenous catheter placement.
Perform collection of other specimens including but not limited to nasopharyngeal swabs and saliva.
Administer study products to randomized participants including but not limited to intramuscular and subcutaneous injections and intravenous infusions while adhering to study protocol and Good Clinical Practices (GCP).
Provide education about COVID-19, HIV, and sexually transmitted infections.
Perform HIV risk assessments and risk reduction counseling, including testing for HIV and sexually transmitted infections.
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.
Serve as a resource for non-clinical staff.
Develop and maintain research procedures with the goal of standardization, increase efficiency and ensure compliance with all guidelines, protocols and federal regulations.
Oversee the development and maintenance of SOP’s.
Assess, design, and evaluate research protocol requirements for study implementation.
Assure careful compliance with Institutional Review Board (IRB) standards and policies in all study activities.
Perform additional related duties as needed.
Bachelor's degree or equivalent in education and experience, plus four years of experience; or Master's degree or equivalent in education and experience, plus one to two years of experience
Current New York State license, as well as applicable board certification
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
Minimum of 2-4 years of experience conducting clinical trials
Infectious disease clinical and/or research experience
Prior experience with phlebotomy and peripheral intravenous catheter placement for infusions
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.