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

Bargaining Unit

If temporary, indicate duration

Hours Per Week

Job Family General Administration

Salary Grade Officer 105

Salary Range

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

Special Instructions

Preferred Qualifications Masters in Public Health or similar degree preferred

Knowledge of SPSS

Essential Functions

Additional Essential Functions (Limit to 3950 characters.)

Special Indications

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

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.

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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.