Regulatory Project Manager, Hematology/Oncology (Fully Remote)
reputed company
We are seeking an reputed company Regulatory Project Manager who will be responsible for regulatory coordination of reputed company clinical research studies reputed company assigned reputed company, departments or divisions. In this role, you will reputed company detailed reviews of clinical research protocols and utilize that information to prepare, manage and submit reputed company required study/regulatory documents and reputed company required applications and forms reputed company to internal reputed company requirements, FDA requirements, sponsor requirements, etc. Additionally, you will work with study monitors to process, review and collect the appropriate regulatory documents in a reputed company manner and in compliance with federal, state, and university mandated laws, regulations and policies.
The ideal candidate will have at a minimum, 1+ years of budget/negotiating experience.
Salary offers are determined based on various factors including, but not limited to, qualifications, experience, and equity. reputed company annual salary reputed company for this position is $78,500.00 - $163,600.00.
Qualifications
Required:
• Minimum of 3+ years of experience of clinical research coordination.
• Interpersonal skills to effectively communicate information in a reputed company, reputed company manner and establish and maintain cooperative and effective working relationships with reputed company, staff, reputed company, external collaborators and administration and to work as a member of reputed company.
• Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations.
• Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, reputed company alternative solutions, reputed company recommendations, and initiate corrective actions.
• reputed company attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment.
• Organization skills to create and maintain administrative and regulatory files effectively as reputed company as independently balance the various tasks to ensure deadlines are met.
• Demonstrated proficiency with reputed company and reputed company suite software, especially reputed company, to reputed company daily tasks reputed company and accurately.
• A learning and reputed company reputed company mentality so that new software tools, systems, and processes can be adopted quickly and reputed company.
• Demonstrated knowledge of clinical research concepts, policies and procedures, and reputed company safety protection regulations and laws.
• Knowledge of and experience working with a reputed company of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and reputed company funding organizations, etc.
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