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| Job #03087 |
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| About our client |
| Our client is a rapidly growing pharmaceutical company headquartered in North Dakota that is focused on the development and commercialization of various oncology therapeutics. They have an experienced management team and a strong corporate culture. This is a good opportunity for the right candidate. |
| Position |
Location |
| Clinical Research Associate |
North Dakota |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Work with RA Team members and outside investigators (directly), to participate in study development and execution 2) Coordinate activities and clinical proposals of multiple outside investigators 3) Develop and implement clinical protocols 4) Analyze, evaluate and report results of clinical studies 5) Ensure that the collection quality of data from patient charts, medical records, interviews, questionnaires, diagnostic tests, etc. are complete and documented appropriately 6) Design and/or review CRFs and ICFs 7) Develop the Clinical Management Plan and associated study documents such as monitors' reference manual and the study reference manual 8) Develop/maintain monitoring strategy and activities, including identifying non-conformity with company procedures and SOPs 9) Manage the company’s overseas staff 10) Perform other essential tasks as assigned |
| Requirements |
1) BA/BS or MS in Life Sciences, Engineering, or any healthcare-related discipline 2) 3 years of experience in the medical device industry (manufacturing environment preferred) 3) Expertise in medical writing and clinical study design 4) Knowledge of clinical research procedures and FDA guidelines regarding the conduct of clinical research 5) Excellent organizational skills with keen attention to detail 6) Excellent communication and writing skills 7) Good knowledge of MS Office, Internet, databases, etc. 8) Ability to react to change productively 9) Willingness to travel to Asian countries (up to 50%) |

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