Job Title: Clinical Research ManagerWe have openings for a Project Manager, Clinical Operations with the largest, most comprehensive and integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care! Apply Now for more info! Description:
Manages multiple clinical trials.
Oversees reports and assists with statistical analysis.
Assists study team in the preparation of all audits performed by various governing agencies, study monitors, and other compliance efforts.
Oversees and drives projects from concept to final deliverables in form of publications, clinical study reports, final reports to funding agency, etc.
Acts as a liaison between the investigator and funding agency, and third party contractors for study-specific issues.
Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Sponsors,
Regulatory Specialists Contract Research Organizations, and employees of Hackensack University Medical Center.
Coordinates preparation of and assists with the development of protocols, informed consent forms, monitoring and validation plans.
Oversees submission of IND Application to FDA as needed.
Designs case report forms and liaises with data analyst for database development.
Coordinates study manuals of procedures for site coordinators, pharmacists, and laboratory technicians.
Develops and presents training materials for investigators, coordinators, pharmacists, laboratory technicians, and monitors.
Verifies trials are progressing according to quality standards and federal regulations.
Guides on-site monitors by providing training, identifying issues to address on site; assist with resolution of issues and tracking corrective action plans (if CRO)
Arranges, prepares for, and documents meetings between clinical researchers, sponsors, and coordinating center members.
Builds research infrastructure to support multi-center clinical trials.
Performs project management for ad hoc JTCC projects as needed.
Adheres to the standards identified in the Medical Center's Organizational Competencies.
Additional Skills & Qualifications:
Bachelor's degree in a scientific or medical discipline with at least 6-8 years of experience in clinical research.
Experience in clinical protocol and trial document development.
Solid knowledge of Good Clinical Practice guidelines and Protection of Human Subjects regulations.
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