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| Job #02602 |
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| About our client |
| Our client is an established boutique CRO. Considered a "small-to-mid-sized" company, much of their business is repeat business. They focus on smaller trials and deliver high-quality results. |
| Position |
Location |
| Clinical Research Associate |
Midwest, USA |
| Salary |
Reports to |
| Highly competitive package, commensurate with experience | Management |
| Responsibilities |
1) Perform routine site visits, including pre-study, initiation, interim and closeout visits 2) Visit and monitor the proper informed consent procedures
3) Ensure compliance with protocol, GCP/ICH guidelines and other applicable
regulatory requirements and good site performance
4) Review (in detail) subject records, essential documents, investigational
product disposition and accountability, site personnel and procedures 4) Perform tasks with minimal support from management 5) Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment and understanding of study requirements 6) Maintain the home-office (e.g., procurement of office supplies, submission of documents, etc.) |
| Requirements |
1) Bachelor’s level degree in Life Sciences, Pharmacy, Nursing or RN preferred 2) Minimum 2 years of clinical monitoring experience 3) Experience of home-based office 4) Minimum 2 years of clinical monitoring experience in phases II or III 5) Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements 6) Ability to work independently in a fast-paced environment 7) Strong communication, interpersonal and organizational skills 8) Willingness to travel – up to 65% (usually less) |

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