Project Manager, Phase I Research
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The Project Mgr, Phase I Research is responsible for developing and implementing comprehensive workflows and project/patient tracking procedures and tools to ensure ongoing clinical trial compliance across the Phase I Oncology Research Program. This includes, but is not limited to, overseeing and driving the clinical research trials conduct process to final deliverables in a timely and effective manner. The project manager will manage, collaborate and communicate with teams of investigators and research staff to ensure continual process development and improvement always emphasizing clarity in training and implementation with the highest standards of integrity. In collaboration with clinical investigators, the Project Manager will be responsible for developing clinical trial and patient flow manuals of procedures, and other necessary tools and documents required for conduct of Phase I clinical trials. In addition, the Project Manager will be responsible for the oversight and ongoing conduct of all Oncology Phase I Clinical Trials being conducted at the John Theurer Cancer Center.
A day in the life of The Project Manager, Phase I Research at Hackensack Meridian can be described as follows:
1. Project Manage multiple Phase I clinical trials.
2. Oversee reports and assists with ongoing analysis of performance and workflows.
3. Assists study team in administrative aspects of clinical trial conduct and facilitate all aspects of various governing agencies, study monitors, and other compliance efforts.
4. Oversees and drives projects from concept to final deliverables as defined by study protocols.
5. Act as a liaison between the investigator and funding agency, and third party contractors for study-specific issues.
6. 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.
7. Coordinates preparation of and assists with the development of protocols, informed consent forms, monitoring and validation plans.
8. Oversee processing and submission of IND Safety Reports.
9. Liaise with data coordinators to ensure timely processing of all data issues.
10. Develops and presents training materials for investigators, coordinators, pharmacists, laboratory technicians, and monitors.
11. Verify trials are progressing according to quality standards and federal regulations. 1
2. Guides on-site monitors by assisting in training, identifying issues to address at site level; assist with resolution of issues and tracking corrective action plans.
13. Arrange, prepare for, and document meetings between clinical researchers, sponsors, and coordinating center members. 1
4. Build research infrastructure to support multi-center Phase I clinical trials.
15. Perform project management for ad hoc JTCC projects as needed.
16. Ability to sit and concentrate at a computer workstation for a minimum of 4 hours at a single sitting.
17. Adheres to the standards identified in the Medical Center's Organizational Competencies.
Education, Knowledge, Skills and Abilities Required:
1. Bachelor's degree in a scientific or medical discipline with at least 3 years of experience in clinical healthcare environment.
2. Experience in clinical office management and workflow.
3. Solid knowledge of Good Clinical Practice guidelines and Protection of Human Subjects regulations.
4. Expertise in MS Word and Excel, including the ability to solve technical problems with documents and templates; proficiency with Access and a variety of database applications; experience with EndNote and Adobe Acrobat.
Licenses and Certifications Preferred:
1. Society of Clinical Research Associates Certification.
As a courtesy to assist you in your job search, we would like to send your resume to other areas of our Hackensack Meridian Health network who may have current openings that fit your skills and experience.
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