Kelly Services is currently seeking a In-House CRA for a long-term engagement with one of our Global Pharmaceutical clients in Jacksonville FL. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
The In-House CRA is based in the client’s facility and will provide clinical research support and assistance in overseeing the conduct of clinical trials.
Ensure the clinical trials adhere to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines, and other government regulations.
Exercise good clinical judgment and demonstrate professional conduct when interacting with investigational site personnel and Sponsor representatives.
Responsible for the management of assigned clinical trials from study start to close out. Duties will include analysis of potential subject recruitment, investigator recruitment and selection, conducting site initiation meetings, assisting with the preparation of protocols, creating informed consent forms, electronic data capture (EDC) testing, organizing IRB and/or EC submissions with follow through to ensure successful outcome, monitoring clinical data, trial master file (TMF) maintenance, etc.
Oversee Clinical Research Organizations (CROs), when applicable.
Approximately 5% local travel for on-site monitoring, as needed.
Bachelor’s degree required
1-3 years CRA experience preferred
Clinical Research Coordinator (site-level Study Coordinator) experience is required in lieu of CRA experience for In-House CRA I position
On-site monitoring experience is preferred
EDC experience required (non-discriminatory)
Excellent oral and written communication skills required
Willingness to travel up to 5% (as-needed basis) in Southeast US for on-site monitoring required
Ability to work in a fast-paced environment while maintaining quality
Ability to adapt to change
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