
Project Manager, Clinical Trials
- Hackensack, NJ
- $100,000-126,000 per year
- Permanent
- Full-time
- Manage 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.
- 8+ 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.
- Experience with informed consent forms, investigational device exemption, serious adverse event reporting.
- Experience with IND safety reports and Institutional Review Board procedures.