Clinical Research Associate |
| July 28, 2010 - August 15, 2010 |
| Location: | Minneapolis, MN |
| Exempt/Non-Exempt: | Exempt |
| Employment Type: | Full Time |
| Department: | Medicine Research |
| Description: | Schedule and conduct monitoring activities at assigned centers assessing site compliance to assure adherence to good clinical practices, standard procedures, and study protocols. May participate in the study development and start-up process. |
| Duties: | Discuss monitoring visit findings with site personnel and complete written reports.
Identify and track monitoring action items.
Review regulatory documents.
May participate in the study development and start-up process.
Review protocols, design and/or review CRF�s, prepare Informed Consent forms, develop study
documents, organize and present at investigator meetings, work with management on monitoring strategy, and/or develop specific training.
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| Qualifications: | Any equivalent combination of education and experience that provides the required knowledge and skills is qualifying. Typical qualifications would be a Bachelors degree in Medical Sciences, Nursing, or related field, and 1-2 years experience in clinical research. Experience in clinical research monitoring preferred.
Requires interaction with a diverse population. Ability to travel an average of 65% depending on project needs. Skilled in problem solving and keeping detailed records and files. Demonstrate proficiency in word processing, spreadsheet, and presentation computer software applications. Knowledge of research design, protocols, and analysis; and knowledge of regulatory aspects of clinical research. Ability to produce professional correspondence, presentations, reports and training materials. Ability to recognize reportable adverse events when reviewing patient charts. Ability to constructively interact with range of personalities and positions both inside and outside the organization. Ability to work independently, be self-directed and motivated, and communicate effectively. Displays high standards of attendance, punctuality, maintains confidentiality, effective time management. |
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