Columbia University
Clinical Project Coordinator
Columbia University, New York, New York, us, 10261
Job Type: Officer of AdministrationBargaining Unit:Regular/Temporary: RegularEnd Date if Temporary:Hours Per Week: 35Standard Work Schedule:Building:Salary Range: $62,400.00 - $65,00.00
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Position SummaryThe Clinical Project Coordinator (CPC) will be working with Principal Investigators to coordinate multi-center research studies of Parkinson's Disease, Alzheimer's disease, and possibly other neurological/psychiatric diseases. The CPC is an essential member of the research team.ResponsibilitiesResponsibilities include but are not limited to:Clinical:Identify, recruit, and consent eligible participants; conduct visits as outlined in study protocols and accordance with Good Clinical Practices (GCP) and HIPAA guidelines.Perform research-related services, such as coordinating study visits, scheduling study visits, data collection, data entry, and transmission.Perform research visits, including study questionnaires and patient assessments.Collect data and complete case report forms for all study visits through research visits, chart abstraction, or telephone, as required by the protocol and consistent with GCP, HIPAA, FDA/HHS, and state and institutional regulations.Responsible for collecting, transporting, processing, and shipping blood samples in accordance with federal, state, and institutional policies.Create, prepare, and maintain research protocols for the Institutional Review Board (IRB) to ensure compliance with research and ethical requirements; report to IRB regarding research-related changes or events.Interface with various hospital departments and additional centers for material such as medical records, the CTSA, the IRB/HRPO, and others as needed.Coordinate protocols and human subject approvals between various sites.
Research:Create and maintain patient research records. Enter research data into study-specific electronic databases.Coordinate research data collection between multiple sites.Conduct basic statistical analysis; assist with the preparation of study publications and presentations.
Grant:Assist PI in drafting and preparing all grant applications (clinical, non-clinical, basic, etc.)Collaborate with PI, internal and external departments and divisions to create categorized budgets and justifications. Confirms accuracy and completeness of all budgeted costs.Partner with OSP, SPA, Finance, Division Administrator for all grant submissions and matters.Track award financial and progress milestones.Connect with appropriate team/department to fulfill such requirements and remain compliant with award terms and conditions.Assist PIs in preparing new protocol submissions, protocol amendments, and renewals of ongoing studies.Collaborate with PIs to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol.Prepare, establish, and organize other study materials. These study materials include but are not limited to, the informed consent document, case report forms (CRFs), and enrollment logs.
Project Coordination and Management:Coordinate research projects across various performance sites; ensure research compliance with sponsor requirements and timely submission of progress reports.Coordinate regular meetings for administrative, grants, and scientific updates. Track research progress and data and resource sharing among research networks.Ensure that all aspects of a project are organized and in conformance with timeline and deliverables requirements.Report project risks and outcomes to appropriate management channels and escalate issues according to project work plan.Serve as point of communication between company teams and external resources.Deepen partnerships with outside resources, including third-party vendors and researchers.
Other:Assist with and conduct routine and standardized experiments for relevant research projects.Petty cash management and disbursements.Perform other related duties and responsibilities as assigned/requested.
Minimum QualificationsBachelor's degree or equivalent in education and experience required.Proficient record-keeping skills, organizational, and time management skills.Proactive, adaptive, strong work ethic.Experience in coordinating teams and clients.Proven success in a corporate or higher-education setting, working with all levels of management.Strong written, oral, and presentation skills.Willing to travel and attend domestic and international conferences.
Preferred Qualifications2+ years in Basic or Clinical research.3+ years of experience in project coordination.Works well independently and in a team setting with a broad spectrum of patients, scientists, medical personnel, and administrative departments.Professional certification such as PMP (Project Management Professional).Experience with Medical Records, RedCAP, IRB protocols.Prior experience in building grant proposals, budgets, applications for various sponsors (i.e. NIH, DOD, Foundations).
Equal Opportunity Employer / Disability / VeteranColumbia University is committed to the hiring of qualified local residents.
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Position SummaryThe Clinical Project Coordinator (CPC) will be working with Principal Investigators to coordinate multi-center research studies of Parkinson's Disease, Alzheimer's disease, and possibly other neurological/psychiatric diseases. The CPC is an essential member of the research team.ResponsibilitiesResponsibilities include but are not limited to:Clinical:Identify, recruit, and consent eligible participants; conduct visits as outlined in study protocols and accordance with Good Clinical Practices (GCP) and HIPAA guidelines.Perform research-related services, such as coordinating study visits, scheduling study visits, data collection, data entry, and transmission.Perform research visits, including study questionnaires and patient assessments.Collect data and complete case report forms for all study visits through research visits, chart abstraction, or telephone, as required by the protocol and consistent with GCP, HIPAA, FDA/HHS, and state and institutional regulations.Responsible for collecting, transporting, processing, and shipping blood samples in accordance with federal, state, and institutional policies.Create, prepare, and maintain research protocols for the Institutional Review Board (IRB) to ensure compliance with research and ethical requirements; report to IRB regarding research-related changes or events.Interface with various hospital departments and additional centers for material such as medical records, the CTSA, the IRB/HRPO, and others as needed.Coordinate protocols and human subject approvals between various sites.
Research:Create and maintain patient research records. Enter research data into study-specific electronic databases.Coordinate research data collection between multiple sites.Conduct basic statistical analysis; assist with the preparation of study publications and presentations.
Grant:Assist PI in drafting and preparing all grant applications (clinical, non-clinical, basic, etc.)Collaborate with PI, internal and external departments and divisions to create categorized budgets and justifications. Confirms accuracy and completeness of all budgeted costs.Partner with OSP, SPA, Finance, Division Administrator for all grant submissions and matters.Track award financial and progress milestones.Connect with appropriate team/department to fulfill such requirements and remain compliant with award terms and conditions.Assist PIs in preparing new protocol submissions, protocol amendments, and renewals of ongoing studies.Collaborate with PIs to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol.Prepare, establish, and organize other study materials. These study materials include but are not limited to, the informed consent document, case report forms (CRFs), and enrollment logs.
Project Coordination and Management:Coordinate research projects across various performance sites; ensure research compliance with sponsor requirements and timely submission of progress reports.Coordinate regular meetings for administrative, grants, and scientific updates. Track research progress and data and resource sharing among research networks.Ensure that all aspects of a project are organized and in conformance with timeline and deliverables requirements.Report project risks and outcomes to appropriate management channels and escalate issues according to project work plan.Serve as point of communication between company teams and external resources.Deepen partnerships with outside resources, including third-party vendors and researchers.
Other:Assist with and conduct routine and standardized experiments for relevant research projects.Petty cash management and disbursements.Perform other related duties and responsibilities as assigned/requested.
Minimum QualificationsBachelor's degree or equivalent in education and experience required.Proficient record-keeping skills, organizational, and time management skills.Proactive, adaptive, strong work ethic.Experience in coordinating teams and clients.Proven success in a corporate or higher-education setting, working with all levels of management.Strong written, oral, and presentation skills.Willing to travel and attend domestic and international conferences.
Preferred Qualifications2+ years in Basic or Clinical research.3+ years of experience in project coordination.Works well independently and in a team setting with a broad spectrum of patients, scientists, medical personnel, and administrative departments.Professional certification such as PMP (Project Management Professional).Experience with Medical Records, RedCAP, IRB protocols.Prior experience in building grant proposals, budgets, applications for various sponsors (i.e. NIH, DOD, Foundations).
Equal Opportunity Employer / Disability / VeteranColumbia University is committed to the hiring of qualified local residents.