Sr Clinical Research Associate
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.
Sthree US is acting as an Employment Business in relation to this vacancy.