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Clinical Research Associate

RESPONSIBILITIES & ACCOUNTABILITIES
o Identifies project expectations and ensures required activities and documentation occur and are appropriately maintained.
o Operates within the project parameters while ensuring compliance with applicable regulatory, internal and project-specific requirements.
o Ensures protocol adherence and addresses non-compliance issues, as appropriate.
o Participates in the writing of standard operating procedure documentation related to project management.
o Participates in the training of personnel and study sites and sponsors.
o Participates in meeting preparation activity(ies) and/or attends sponsor meetings.
o May serve as the primary liaison with sponsor and sponsor-designated representatives.
o May communicate directly with either the sponsor (or designee) or directly with clinical sites to coordinate personnel training and equipment credentialing, as well as assessment of data transfer capabilities.
o May be required to participate in internal and external project-related audits and audit-related activities.
EDUCATION & EXPERIENCE
o Undergraduate degree, preferably in a science or business, preferred.
o Requires experience with clinical trials operations or an equivalent combination of education and experience.
o At least 1 year of clinical trial experience.
o Proficient in Microsoft Word, Excel, PowerPoint and experience using database software.
o Excellent written and oral communication skills.
o Excellent organizational skills and attention to detail.
o Strong interpersonal skills and the ability to work with deadlines and manage multiple priorities.


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