Job Description
The Project Manager in Clinical Trials will oversee multiple investigator-initiated clinical trials, ensuring the successful management and execution from concept to final deliverables. This role involves collaboration with research team members, acting as a liaison between investigators, funding agencies, and third-party contractors, and overseeing compliance efforts and statistical analysis.
ResponsibilitiesManage multiple investigator-initiated clinical trials.Oversee reports and assist with statistical analysis.Assist study teams in preparing audits for governing agencies and study monitors.Drive projects to completion, resulting in publications and clinical study reports.Act as a liaison between investigators, funding agencies, and third-party contractors.Collaborate daily with Principal Investigators, Research Nurse Coordinators, Sponsors, Regulatory Specialists, and Contract Research Organizations.Coordinate preparation and development of protocols, informed consent forms, monitoring plans, and validation plans.Oversee submission of IND Applications to FDA as needed.Design case report forms and liaise with data analysts for database development.Coordinate study manuals of procedures for site coordinators, pharmacists, and laboratory technicians.Develop and present training materials for investigators and coordinators.Verify trials progress according to quality standards and federal regulations.Guide on-site monitors, providing training and resolution of issues.Arrange, prepare, and document meetings between clinical researchers, sponsors, and coordinating center members.Build research infrastructure to support multi-center clinical trials.Perform project management for ad hoc JTCC projects as needed.Adhere to standards identified in the Medical Center's Organizational Competencies.Essential Skills8+ years of clinical research experience.Bachelor's degree in a scientific or medical discipline.Experience in clinical protocol and trial document development.Solid knowledge of Good Clinical Practice guidelines.Understanding of Protection of Human Subjects regulations.Additional Skills & QualificationsExperience with informed consent forms, investigational device exemption, serious adverse event reporting.Experience with IND safety reports and Institutional Review Board procedures.Pay and Benefits
The pay range for this position is $100000.00 - $126000.00/yr.
Hackensack Meridian Clinical Project Manager
Workplace Type
This is a hybrid position in Hackensack,NJ.
Application Deadline
This position is anticipated to close on Aug 12, 2025.
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