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 Clinical Research Project Manager in the Department of Anesthesiology, Divisions of Critical Care Medicine and Cardiac Anesthesiology, will be responsible for managing the clinical trial projects in the lab. The lab conducts a variety of clinical research studies, including studies of sepsis, cognitive dysfunction, delirium, mechanical ventilation, and complications after surgery. This position generally reports to the Division Chief(s) of Critical Care Medicine and Cardiac Anesthesiology.
Responsibilities
Provide leadership in developing and implementing clinical trial projects. Work closely with senior administrators to facilitate the team's work and coordinate or manage the team's initiatives and projects.
Supervise research coordinators to ensure good clinical practice in research.
Manage multiple large and smaller complex clinical trial projects simultaneously.
Partner with sponsors and team leaders to strategize team project plans. Focus on critical success factors, project milestones, and deliverables and develop contingency plans.
Lead project team meetings, including reviewing action plans and tracking project milestones. Update action plans weekly and prompt accountable individuals to ensure timely task completion. Support activities of project teams and maintain accurate documentation of team minutes.
Design communication strategies for project progress. Ensure timely and consistent communication of project priorities, status, timelines, and deliverables to the user community.
Design data collection methods and data analyses to support team efforts. Interpret and report data to various audiences and use data to make recommendations for process improvements.
Ensure appropriate project prioritization and requests for resources. Ensure projects are managed and delivered on time, within budget, and meet the strategic and operational needs of the department.
Understand the requirements of various ethical and regulatory bodies, guiding the study in conforming to those requirements, and coordinating any necessary audit processes.
Prepare study materials and establish procedures to ensure adherence to study protocols and administrative requirements.
Lead the recruitment, training, appraisal, retention, and supervision of study team members.
Coordinate applications, and subsequent amendments, to ethical and regulatory bodies.
Perform site visits to facilitate study setup and initiation, regular monitoring visits during patient recruitment, and close-out visits on study completion.
Lead study oversight groups by organizing and facilitating meetings, providing reports and documentation to committees, and following up on agreed actions.
Ensure timely recruitment of study participants with secure randomization processes and subsequent efficient and effective data management.
Ensure that all study adverse events are appropriately investigated by the study staff and accurately reported to the investigators and regulatory bodies as required.
Monitor study progress to ensure compliance with and adherence to the study plan, and identify, evaluate, and rectify problems.
Support investigators in the collection and monitoring of study data and liaise with collaborators, study doctors, and the data manager to ensure follow-up information is kept up-to-date, accurately completed, and that loss of patient data is kept to a minimum.
Prepare research progress and monitoring reports, organize and minute regular meetings with the appropriate Steering Committee and Data Monitoring Committees, ensuring compliance with Research Governance, Good Clinical Practice, Data Protection, and ethical requirements, as applicable.
Provide regular and ad-hoc information, both written and verbal, to all study participants and sponsors, including reports, updates, guidance, preformed commitments, and possibly a newsletter, or similar, as appropriate.
Coordinate the preparation and publication of data, reports, and information, ensuring compliance with applicable contractual and ethical requirements.
Ensure the inclusion of patients and public involvement and engagement group representatives at the appropriate levels and times.
Act as the first point of contact for all external and internal agencies.
Minimum Qualifications
Bachelor's degree or equivalent in education and experience, plus four years of related experience
Preferred Qualifications
Master???s degree in business or healthcare preferred, with 3-5 years of related work experience
CITI Certification preferred
Other Requirements
Minimum computer skills:
Proficiency with word processing, spreadsheet programs and MAC???s required.
Advanced skills with Microsoft applications, including Outlook, Work, Excel, PowerPoint, or Access, and other web-based applications.
Ability to produce complex documents, perform analysis, and maintain databases.
General skills:
Experience in meeting facilitation and the ability to lead group discussions.
Ability to make decisions guided by general instructions and practices requiring some interpretation. May make recommendations for solving problems of moderate complexity and importance.
Ability to address highly varied, complex, and often non-recurring problems requiring staff input, innovative, creative, and Lean diagnostic techniques to resolve issues.
Ability to set goals and determine how to accomplish defined results with some guidelines. Manager/Director provides broad guidance and overall direction.
Ability to summarize and communicate moderately complex information in varied written formats to internal and external parties.
Ability to lead collaborative teams for larger projects or groups both internal and external to the Medical Center and across functional areas. Results have implications for the management and operations of multiple areas of the organization.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.
