Project Manager
Credit Suisse
Contract New York, New York, United States Posted 3 years ago
About Position
Project Manager (Contract)
$75.00 / Hourly
New York, New York, United States
Project Manager
Contract New York, New York, United States Posted 3 years ago
Skills
• Bachelor’s degree is preferred; A High School Diploma with experience in clinical research or applicable experience. • At least 3.5 years in a clinical research function or as determined by hiring manager; relevant graduate work would be considered in lieu of total minimum experience (adjusted appropriately). • Strong ability to work independently be flexible and meet goals. • Prior supervisory experience a plus • Familiarity with computer systems databases data analysis and data reporting is essential. • Extensive knowledge and understanding of the regulations pertaining to human subject protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA).Description
• Supervise the day-to-day activities of Research Regulatory Associates (RRAs) to ensure efficient and effective operations.
• Manage a quality assurance program by reviewing research for accuracy and compliance.
• Support the work of attendings, fellows and research staff to accomplish research goals.
• Prepare and submit new studies to the Protocol Activation Core (PAC) and ensure all the necessary study tools are completed prior to study activation
• Ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project and/or database.
• Perform quality checks of drafted deviations for reporting to the IRB/PB in regulatory compliance as appropriate
• Prepare waivers and data use agreements (as needed) for service research projects.
• As needed, ensure that Serious Adverse Events (SAEs) are completed and reported to the SAE Manager in the IRB/PB, Office of Clinical Research and, if necessary, the sponsor.
• Ensure proper submission of single patient use trials and exception letters to the IRB/PB.
• Oversee audit and inspection readiness tasks performed by direct reports and other members of the team
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