Regulatory Assistant
About The Position
The primary purpose of this position is to provide regulatory document support within the Regulatory staff the Lineberger Clinical Protocol Office. The Regulatory Assistant prepares and ensures the completion of essential documents by clinical research personnel, accurately maintains the regulatory binder for clinical research studies, and communicates regularly with study sponsors, investigators, and LCCC staff regarding the status and completion of essential regulatory documents. This work is performed in order to comply with federal, state, and local laws, regulations, and guidance applicable to the conduct of oncology clinical research. Regulatory Assistants participate in the collection, compilation, and management of data/information; quality assurance and quality control; analysis by statistical or other means; generation/production of new data/information; and editing and formatting of reports. Regulatory Assistants are expected to use considerable judgment and research skills in performing their work assignments. Work may include the training of staff and others.
Requirements
- Working knowledge and facility with information technology, including Microsoft Outlook, Word, Excel, and PowerPoint
- Ability to organize, record, and present information
- Ability to lead exchange of information through dialog, instruction, and demonstration
- Ability to develop working knowledge of regulatory requirements and procedures relating to essential document collection for oncology clinical research
- Ability to communicate professionally both verbally and in writing
Nice To Haves
- Knowledge of regulatory policy relating to clinical research and institutional review boards
Responsibilities
- Prepares and ensures the completion of essential documents by clinical research personnel
- Accurately maintains the regulatory binder for clinical research studies
- Communicates regularly with study sponsors, investigators, and LCCC staff regarding the status and completion of essential regulatory documents
- Participate in the collection, compilation, and management of data/information
- Quality assurance and quality control
- Analysis by statistical or other means
- Generation/production of new data/information
- Editing and formatting of reports
- Training of staff and others
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
Number of Employees
11-50 employees
