A global Clinical Research Institute located on the East Coast is seeking to hire a Clinical Research Associate for an exciting opportunity. This Institute prides themselves on being proactive and hands-on at the site level.
Clinical Research Associate will be responsible for:
- Review investigational site and CRO performance deliverables, study data, and metrics to determine potential study risks.
- Review study and investigational site eTMF files for completeness and appropriate document completion.
- Provide oversight to the CRO CRAs in the field, evaluating their performance according to the Project Work Order, Monitoring Plan, and source document verification (SDV).
- Assist in the selection and recruitment of investigational sites.
- Perform on-site monitoring (pre-study, initiation, routine, and close-out visits) at clinical study sites to assure adherence to GCPs, SOPs, and study protocols.
- Education Requirement: Bachelors of Science/Arts in the life sciences or a health-related field.
- Must have at least 3 years of monitoring experience with a focus in multiple therapeutic areas.
- Previous experience addressing escalated investigational site issues to resolution is a must.
- Must have working knowledge of GCP, ICH guidelines, and FDA regulations.
- The ideal candidate has the ability to work independently and on a team.
- Proficiency with MS Office (Word, Excel, PowerPoint, and Outlook) and clinical trial software.
- He/she needs excellent oral and written communication skills and strong organizational abilities.
- Experience on the sponsor side is highly preferred and desired.
Culture. Fun positive enjoyable environment. Family feel. Great atmosphere.
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