Columbia University Project Manager in New York, New York
Job TitleProject Manager
Job Code Title
Job Requisition Number 095732
Department 7525- NEU Neurology
Location Medical Center
Job Type Officer Full-Time Regular
If temporary, indicate duration
Hours Per Week
Job Family Project/Program Management/Planning
Salary Grade Officer 105
Advertised Summary Job Description The Division of Neurology Clinical Outcomes research and Population Sciences seeks an experienced, energetic, highly motivated, organized, autonomous person with excellent multi-tasking ability, supervisory and record-keeping skills. The successful candidate will have specific management responsibilities for a large clinical trial implemented at 120 + sites within StrokeNet, a national clinical trials network.
The Project Manager is a specialized research professional working in tandem with another Project Manager located at the National Coordinating Center at the University of Cincinnati. The Project Managers work under the direction of the four Principal Investigators. While the PIs are primarily responsible for the overall design, conduct, and management of the clinical trial, the Project Managers facilitate and coordinate the daily activities and play a critical role in the oversight of the individual sites' recruitment, retention, and conduct of the trial. The Project Manager will also need to work with individual site PIs around the US, individual sites' study coordinators, the National Coordinating Center in Cincinnati, the National Data Management Center in South Carolina, the sponsor at the NIH, and the pharmaceutical company providing study medication.
Develop a collaborative relationship with NCC PM
Assist sites in trial start-up, readiness calls and document review
Assist with monitoring of recruitment, retention and implementation of trial and site recruitment strategies
Coordinate study wide newsletters and subject recruitment materials
Coordinate weekly Operations calls
Provide guidance and supervision to enrollment sites' study staff (iIn collaboration with NCC PM)
Provide assistance to sites regarding the shipment and supplies for the CALM laboratory (In collaboration with Core Lab Director and team)
Work closely with the National Data Management Center (NDMC) at MUSC providing guidance and review of trial related regulatory documents
Maintain detailed knowledge of the study protocol and associated assessments and procedures
Assist the NCC Project Manager and PIs with data safety monitoring compliance and NIH reporting
Manage local regulatory affairs including IRB submissions, collecting regulatory documents
Attend investigator meetings
Participate in Operations meetings and assist with monthly webinars
Create and manage study progress on the Clinical Trials.gov protocol registration system
Assist the local Study Coordinator for the trial
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 and experience, plus four years of related experience.
Additional Position-Specific Minimum Qualifications
Applicant MUST meet these minimum qualifications to be considered an applicant ? Demonstrated record of dependability, able to manage high level of responsibility.
? At least 5 years' clinical research experience that must include some work on federally sponsored clinical trials.
? Confident and highly motivated with excellent multi-tasking ability and record-keeping skills.
? Outstanding organizational skills with meticulous attention to detail.
? Professional demeanor and excellent interpersonal and communication skills.
? Proven ability to work independently with minimal supervision.
? Ability to work with diverse teams of people in a diplomatic, collaborative and effective manner.
? Ability to problem-solve and establish timelines and priorities.
? Demonstrated understanding of GCP, ICH, and FDA regulations.
? ACRP or SOCRA certified or willingness to become certified.
? Demonstrated ability to handle multiple items simultaneously and produce high-quality work in a timely, accurate and efficient manner.
? Demonstrated oral, written, communication skills.
? Solid record of supervisory experience.
? Excellent attendance record.
? Positive attitude and willingness to help.
? Ability to be flexible and focused in a sometimes fast paced, hectic, ever-changing environment.
? Proficiency in the use of computers and software including Microsoft Office products (Word, Excel, PowerPoint, Outlook).
Preferred Qualifications ? Experience with screening, recruiting, consenting, and data collection for human subjects research.
? Demonstrated success with recruitment for multi-site clinical trials.
? Experience with clinical trials networks.
? Experience with optimization of recruitment and retention strategies.
? Familiarity with electronic data entry, database development, and database management.
? GCP certified; CITI and PEERRS.
? Prior health care and/or research experience.
? Experience with organizing large multi-site meetings.
Additional Essential Functions (Limit to 3950 characters.)
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 11-20-2018
Requisition Close Date Open Until Filled
Quick Link jobs.columbia.edu/applicants/Central?quickFind=173261
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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