Job Information
The Trustees of Columbia University in the City of New York Project Manager in New York, New York
- Job Type: Officer of Administration
- Bargaining Unit:
- Regular/Temporary: Regular
- End Date if Temporary:
- Hours Per Week: 35
- Salary Range:$85,000.00 - 95,000.00
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.
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Position Summary
The Eleanor & Lou Gehrig ALS Center at Columbia University is an integrated clinical care and research center with active ALS clinical and translational research programs. Supporting the Translational Research Unit, the Project Manager (PM) will oversee the start-up and execution of the PREVENT ALS cohort for the NIH-funded Access for All in ALS (ALL ALS) Consortium. PREVENT ALS will enroll and conduct research with individuals who are at risk for developing ALS because of genetic risk factors in their families.
Reporting to the ALS Center's Associate Director and the Translational Research Manager, the PREVENT Project Manager will ensure regulatory compliance with all federal and local agencies including the central and local IRBs. They will collaborate with the ALL ALS coordinating center staff at MGH and the Barrow Neurological Institute to support the 34 PREVENT enrollment sites across the country; ensuring all regulatory documents and requirements are met and maintained, provide strategies for improving efficiency, action plans to improve quality, and provide training and education of personnel. They will help develop and refine case report forms, the PREVENT project website, coordinate a growing cadre of genetic counselors working on PREVENT, and interact with some participants in their participation journey.
Responsibilities
- Managing all regulatory, start-up and operational aspects of PREVENT ALS including IRB CUIMC IRB submissions, communication with and monitoring of satellite sites, budget creation and negotiation, vendor management, operational start-up internally and externally, and execution of reliance agreements as needed
- Facilitating the preparation and execution of Material Transfer Agreements and Data Use Agreements; tracking the progress of such Agreements and their associated sample/data transfers; acting as liaison between SPA/CTV, Columbia researchers, and recipients at other institutions.
- Establishing and maintaining research files and documentation pertaining to regulatory requirements for clinical trials, including CVs, financial disclosure forms, licenses, GCP trainings, CLIA/CAP certificates, and outcomes certifications, and tracking expiration dates of all the above.
- Assisting in developing or modifying case report forms for the PREVENT cohort and coordinate implementation in the electronic data capture system.
- Assisting in developing the patient facing PREVENT website.
- Overseeing the scheduler and genetic counselors that receives and assigns enrollment visits, and at times helping with participant triage
- Representing Columbia University ALS Center during meetings with study monitors, other institutions participating in the ALL ALS Consortium, and representatives from the NIH
- Attending regular research team meetings and updates staff and investigators on the status of regulatory submission and amendments
- Providing training and education to other personnel and participating in centralized activities of the department or institution
- Be available to travel bi-annually to attend ALL ALS or PREVENT cohort study meetings
- Ensuring compliance with all federal and local agencies including the FDA and local IRB
- Maintaining research practices using Good Clinical Practice (GCP) guidelines, strict patient confidentiality according to HIPAA regulations and applicable law and participates in required training and education programs.
Minimum Qualifications
- Bachelor's degree in a related field or equivalent in education and experience, plus and four (4) years of related experience.
- Deep understanding of clinical research protocols and regulations governing clinical research
- Ability to demonstrate professionalism and respect for subjects' rights and individual needs
- Experience interfacing with other sites and other institutional regulatory teams
- Demonstrated ability to work self-sufficiently within an interdisciplinary team
- Excellent organizational, interpersonal, and oral/written communication skills
- Computer literacy and familiarity with data management systems
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Minimum Salary: 31200.00 Maximum Salary: 31200.00 Salary Unit: Yearly