Columbia University Regulatory Coordinator - Nephrology in New York, New York

Job TitleRegulatory Coordinator - Nephrology

Job Code Title 316114

Job Requisition Number 092599

Department 7519- MED Medicine

Location Medical Center

Job Type Officer Full-Time Regular

Bargaining Unit

If temporary, indicate duration

Hours Per Week 35

Job Family Research (Laboratory and Non-Laboratory)

Salary Grade Officer 103

Salary Range Commensurate with experience

Advertised Summary Job Description Under the direction of the Director of Clinical Research and the supervision of the Regulatory Manager, the Regulatory Coordinator will assist the Regulatory Manager and clinical study teams in the start-up and management of clinical studies in the Division of Nephrology.

The Regulatory Coordinator will assist with IRB and FDA submissions, preparing and maintaining protocol-specific regulatory documents, the initiation, implementation and monitoring of the clinical trial process, and generating monthly &/or ad hoc reports. Will serve as a regulatory contact for studies; ensuring that regulatory compliance is met and that regulatory files are audit-ready. Perform other duties as assigned.

Minimum Qualifications for Grade

Applicant MUST meet these minimum qualifications to be considered an applicant Requires a bachelor's degree or equivalent in education, training and experience, plus two years of related experience.

Additional Position-Specific Minimum Qualifications

Applicant MUST meet these minimum qualifications to be considered an applicant Excellent verbal and written communication skills and attention to detail is required. Able to verbally communicate effectively with physicians, nurses, pharmaceutical companies and other team members. Able to communicate effectively when reading and writing emails, letter and other reports.

Working knowledge of applicable federal regulations and guidelines associated with complex clinical trials and research involving human subjects. An understanding of and ability to implement institutional policies, procedures and guidelines as established by the CUMC Office of the Executive Vice President for Research and the CUMC Institutional Review Board.

Computer skills (Word, Excel). Must be able to work effectively with minimal supervision. Must be capable of prioritizing and managing several projects at once and take responsibility for meeting deadlines. Must have the flexibility and willingness to occasionally work evenings and weekends in order to meet research trial deadlines.

Successful completion of institutional Human Subjects Protection, Good Clinical Practices (GCP) and HIPAA certifications will be required.

Special Instructions

Preferred Qualifications Experience in an academic or pharmaceutical clinical trials environment preferred.

Essential Functions

Additional Essential Functions (Limit to 3950 characters.)

Special Indications

This position works with: There are no special indications for this position

HIPAA Compliance training required Yes

Participation in Medical Surveillance required No

What type of posting? Is this a waiver request? Standard Posting

Requisition Open Date 04-26-2018

Requisition Close Date Open Until Filled

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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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