Research Program Manager Jobs

537793
Medical Center
Neurology
Full Time
Opening on: Jul 21 2023
Grade 105
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Job Type: Officer of Administration
Bargaining Unit:
Regular/Temporary: Regular
End Date if Temporary:
Hours Per Week: 35
Standard Work Schedule: Monday-Friday 9am-5pm
Building: 710 W 168th Street
Salary Range: 80,000-110,000
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 Summary
The Eleanor and Lou Gehrig ALS Center at Columbia University is an integrated clinical care and research center with an active ALS clinical and translational research program. As a key member of the management team of the ALS Center, the Research Program Manager will be responsible for the oversight of all investigator-initiated clinical trials authorized by the Food and Drug Administration (FDA) under a research or expanded access investigational new drug (IND) protocol. This includes program management of Silence ALS , a collaborative initiative with the n-Lorem foundation to discover and develop individualized anti-sense therapeutics for patients with rare genetic forms of ALS.
As a direct report to the ALS Center Director, the RPM will work closely with the ALS Center Clinical Research Managers to ensure regulatory compliance with all federal and local agencies including the FDA and local IRB, and accurate data collection and management for clinical trials and research programs initiated by the ALS Center. They will attend team meetings, work with other staff to ensure all regulatory documents and requirements are met and up to date, provide strategies for improving efficiency, action plans to improve quality, and provide training and education of personnel as well as ensure compliance.
Responsibilities
Preparing, submitting, and maintaining compliance of protocols and supporting documents with regulatory bodies such as the FDA, HRPO and IRB, including familiarity with IRB Reliance Agreements, Central IRBs, and Platform-based study models
Managing all regulatory, start-up and operational aspects of Research and Expanded Access (Compassionate Use) IND projects, including IND filing, FDA reporting, 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.
Program management of Silence ALS , an initiative in partnership with the n-Lorem Foundation to discover and develop novel anti-sense therapeutics for individuals with rare genetic forms of ALS, including
Facilitate 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
Entering study visit data into the Clinical Trial Management System for reimbursement; verifying research billing charges in Epic
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
Meeting with monitors and stakeholders from pharmaceutical companies and representing the Columbia University ALS Center during these meetings
Working closely with the Clinical Research Manager, Translation Research Manager, Genetic Counselor, research staff and investigators to assure that all regulatory documents for the research studies are up-to-date and research programs are operationally successful
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 participate in centralized activities of the department or institution
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
Managing 3-4 direct reports
Minimum Qualifications
Requires a bachelors degree and 4 years of experience.
Preferred Qualifications:
Master's degree or equivalent in education and experience, plus 6 years of related experience.
The ideal candidate must also possess:
Deep understanding of clinical research protocols and regulations governing clinical research
Ability to demonstrate professionalism and respect for subjects’ rights and individual needs
Demonstrated ability to work cross-functionally with 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.