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.
Responsibilities - 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
General Minimum Qualifications: Requires a bachelor's degree or equivalent in education and experience, plus four years of related experience.
Additional Specific Minimum Qualifications: ? 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.
As a member of the National Collegiate Athletic Association (NCAA) and the Council of Ivy Group Presidents (Ivy League), it is imperative that members of the Columbia University community, in all matters related to the intercollegiate athletics program, exhibit the highest professional standards and ethical behavior with regard to adherence to NCAA, Conference, University, and Department of Intercollegiate Athletics and Physical Education rules and regulations.
Columbia University is an Equal Opportunity/Affirmative Action employer.
Internal Number: 126_173261
About Columbia University
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