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| Job #02756 |
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| About our client |
| Our client is a world-leading CRO, which has served the pharmaceutical, biotech and healthcare industries for over 25 years. |
| Position |
Location |
| Regional Clinical Research Associate (Office/Home-Based) |
Indiana |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Monitor activities at clinical study sites to
ensure adherence to Good Clinical Practices (GCPs), SOPs and study protocols 2) Review regulatory documents (as required) and prepare site-visit reports 3) Oversee multiple projects and work both independently as well as in a team environment 4) Participate in the study development and start-up process, including reviewing protocols as well as designing and/or reviewing CRFs 5) Prepare Informed Consent Forms (ICFs) and develop study documents
6) Organize and be present at Investigator meetings 7) Work with the management on monitoring strategy and/or developing project-specific CRA training 8) Contribute to clinical training programs and maintain awareness of developments in the field of clinical research (as needed) |
| Requirements |
1) BS/BA 2) 1-year monitoring experience or a combination of on-site monitoring and clinical research coordination experience (oncology preferred) 3) In-depth knowledge of medical terminology and clinical monitoring process 4) Superb therapeutic and protocol knowledge (as provided in company training) 5) Strong orientation towards customer service 6) Excellent interpersonal and organizational skills along with keen attention to detail 7) Computer literacy (MS Office) 8) Exceptional communication (verbal and written) skills 9) Willingness to travel – up to 65% (regionalized, depending on project needs) |

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