Columbia University Clinical Research Manager in New York, New York
Job TitleClinical Research Manager
Job Code Title
Job Requisition Number 095900
Department 7528- OBG OBGYN
Location Medical Center
Job Type Officer Full-Time Regular
If temporary, indicate duration
Hours Per Week
Job Family General Administration
Salary Grade Officer 105
Advertised Summary Job Description The primary role of this position is to support clinical research involving reproductive health and contraception.
Job duties include:
Preparation and completion of feasibility surveys
Contribute to the grant application process
Develop plans for protocol implementation, identify necessary resources and request as appropriate. This includes instruments, equipment and staff.
Determine recruitment objectives and develop systems to monitor and track achievement
Carry out required staff training and provide the direct supervision for research assistants and other staff
Develop all day to day plan and procedures for data collection as well as data confidentiality and data security.
Responsible for mechanisms and details of protocol adherence and for providing administrative back-up to PI
Preparation and submission of annual reports and regulatory information to funding and regulatory agencies
Develop local systems for secure storage of drugs and supplies and be the point of contact for the research pharmacy
Preparation of IRB applications
Preparation and submission of regulatory documentation to the regulatory bodies as relevant
Assist investigators with validation and editing of collected data
Analyze study data and assist in preparing manuscript
Regular collaboration with the PI and other research staff
Lead CRC of project or network
Develop and maintain procedures for organizing work and staff
Attend investigator meetings as needed
Carry out required staff training and provide the direct supervision for assigned staff
Maintenance of study documents and files, such as regulatory binders and CVs etc.
Completion of GCP, HIPPA and applicable regulatory training
Complete certification requirements for assigned protocols
Screen designated schedules or patient lists for eligible subjects
Approach and verify eligibility subjects
Consent and enroll eligible subjects
Complete research study visits as delineated in assigned protocol and manual of operations set forth by sponsor and supervisor.
Complete Telephone follow-up and telephone reminder calls for study participants, during these phone calls the person will need to administer study questionnaire as assigned
Coordinate the collection of all research data points as assigned, whether through research visits, chart abstraction or telephone.
Scheduling of research visits
Collection through venipuncture of biological specimens
Processing, transporting and shipping of biological specimens as assigned and following of instructions as delineated in the protocol or manual of operations.
Completion of study documents and files; some examples might include case report forms, worksheets and medical record notes.
Maintain confidentiality of documents and files such as HIPPA.
Informing relevant clinical staff regarding subject protocol participation.
Assist in other research related activities and projects as needed
Minimum Qualifications for Grade
Applicant MUST 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 MUST meet these minimum qualifications to be considered an applicant ACRP or SOCRA certification
Phlebotomy certificate within 6 months of hire.
Experience in a clinical research setting, especially randomized controlled trials
Capable of working on multiple studies and multi-tasking
Knowledge of medical terminology specifically related to reproductive health and contraception
Excellent interpersonal, written/oral communication, and organizational skills are required
Proficiency in Microsoft Office
Complete proficiency in written and spoken English
Preferred Qualifications Masters in Public Health or similar degree preferred
Knowledge of SPSS
Additional Essential Functions (Limit to 3950 characters.)
This position works with: Bloodborne pathogens
Contact with patients and/or research subjects
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 12-04-2018
Requisition Close Date Open Until Filled
Quick Link jobs.columbia.edu/applicants/Central?quickFind=173495
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.
This organization is a federal contractor subject to the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended by the Jobs for Veterans Act of 2002, 38 U.S.C. 4212 (VEVRAA). The final rules now require contractors and subcontractors to invite applicants to self-identify as protected veterans or individuals with disabilities.
You can update your demographic information by logging in and clicking on "EDIT APPLICATION".
The information is being requested on a voluntary basis, and will be kept confidential. Refusal to provide this information will not subject the applicant to any adverse treatment, and will not be used in a manner inconsistent with the act.