Project Manager -Research Quality

Northwell Health

About The Position

Plans, manages, and coordinates project activities to ensure goals and objectives of multiple and large projects are accomplished within prescribed time-frame and funding parameters. Establishes timelines and ensures project deadlines are met. Maintains integrity and cost containment of projects. We are seeking a Research Quality Manager to support the implementation of a proactive research quality and education program that strengthens investigator readiness and regulatory compliance across the research enterprise. This individual will coordinate education initiatives, conduct targeted operational and regulatory reviews, analyze recurring issues that affect research operations, and assist in translating those insights into practical training, tools, and process improvements for investigators and study teams. The role will also provide support to Research Support Services by periodically assisting with study start-up and maintenance activities to better understand investigator workflows and inform the development of practical resources and training. The successful candidate will place a strong emphasis on the development of efficient and effective workflows and policies that meet the needs of the research community and use data-driven metrics to identify opportunities for continuous improvement.

Requirements

Bachelor's Degree required, or equivalent combination of education and related experience.
1-3 years of relevant experience, required.

Nice To Haves

Support targeted reviews of study files and operational workflows to identify trends that may inform research quality improvement and education efforts.
Analyze findings from operational reviews and assist in translating insights into practical training materials, tools, and guidance for investigators and study teams.
Coordinate and support engaging education and training initiatives across research administration offices to promote consistent guidance for investigators.
Assist with the planning and implementation of projects related to research quality, investigator readiness, and operational improvement, including corrective and preventive actions.
Collaborate with institutional partners to support ongoing research education and quality initiatives.
Compile and organize information from multiple stakeholders to prepare summaries, reports, and materials related to program activities.
Assist with the evaluation of education initiatives and operational improvement efforts.
Periodically assist research support services staff with selected study start-up and maintenance activities, including preparation of IRB submissions, amendments, continuing reviews and study closures, to develop a practical understanding of investigator workflows.
Support investigators and study teams in organizing regulatory materials and contribute to the development or refinement of templates, tools, and training resources that facilitate efficient study management.
Perform related duties as required to support research quality, education, and operational improvement initiatives.
Certified Clinical Research Coordinator (CRC), Certified Clinical Research Professional (CCRP), or similar research credential preferred
Experience coordinating or supporting research education or training initiatives and experience with research quality review, monitoring activities, or protocol compliance assessments preferred
Familiarity with research administration systems such as IRBManager , OnCore , REDCap , or similar systems preferred
Strong attention to detail and demonstrated ability to manage projects and move initiatives through to completion
Demonstrated ability to manage multiple competing priorities and deadlines
Experience supporting federally funded or industry-sponsored clinical research studies
Experience preparing or supporting IRB submissions, amendments, and continuing reviews
Familiarity with federal regulations and ethical principles governing human subjects research, and Strong written and oral communication skills

Responsibilities

Plans, manages, and coordinates projects and ensures project initiatives and timelines are met.
Develops project initiation process by defining project scope, determining action items, assigning ownership, creating project timetables, and tracking execution and workflow; prepares, presents and distributes project status reports.
Evaluates, plans, and monitors project implementation for clinical systems; manages project and project delivery teams, ensures deadlines are met, escalates issues for appropriate, timely resolution and adheres to standardized project management methodologies.
Develops interdisciplinary project teams in coordination with clinical community to ensure deployment of systems; serves as liaison to project sponsors, project teams and stakeholders; works with internal, external groups to optimize success of project deployment.
Communicates with user departments and project teams on project activities; confers with project staff and vendors to provide support and resolve problems; collaborates with clinical, financial and quality teams to define and develop metric goals.
Partners with management to develop tools and metrics to evaluate performance of target initiatives; assists with planning monitoring criteria and methodology.
Ensures availability of performance measurement data for review and analysis; evaluates and drives risk management process improvements, efficiencies and workflow enhancements.
Partners with management, identifies end user education, training program and services; assists in the development and maintains department policies and procedures.
Provides subject matter expert support in the development of clinical information systems and integration to improve the timely completion of projects.
Operates under general guidance and work assignments are varied and require interpretation and independent decisions on course of action.
Performs related duties as required.
All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.