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Cook Medical/Med Institute, Inc. Work Values
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Daily Duties at Cook Medical/Med Institute, Inc.:
- Developed annual data and safety reports to FDA and monthly study status reports to sponsors - Assisted in the development and review of PMAs for Aortic and Peripheral Intervention portfolios and served as project manager in Europe to help prepare data for CE Mark and PMA submissions - Supported the daily activities of global clinical studies - Traveled to investigative sites to perform Site Initiation Visits and support the field monitor when needed - Assisted in planning site visits and the development and review of site visit reports - Maintained a working knowledge of national and international regulations including GCP, 21 CFR 312, 21 CFR 812, ICH GCP, and ISO 14155 - Established trusted relationships with research staff, the project team, and study sponsors - Trained clinical team members as well as served as a resource in North America, Europe, and Asia Pacific - Developed and reviewed various study support documents and submissions to regulatory authorities and IRBs/ECs - Remotely monitored studies by sending and processing queries to ensure the dataset remained complete and accurate - Collected and tracked study-specific documentation to ensure compliance with current regulations for IDE, IND, and post-market studies and registries - Coordinated with research coordinators to prepare and respond to IRB/EC submissions or correspondence - Identified and reported to project management any issues which may need attention at a particular investigative site and supported resolution as needed
What they like about Cook Medical/Med Institute, Inc.:
Working for a company with an emphasis on social values and helping society is a clear and important priority for you - a critical factor in who you choose to work for. In contrast to other factors, you place an organization's reputation for fairness and concern for the community above most other aspects of the company. As you search for a new job opportunity, it is usually possible to find out if the company is involved in the community and/or if it is addressing problems and issues in society. Pay special attention to non-profit organizations and those specifically involved in social action. Moreover, speaking with current and former employees should enlighten you to perceptions of the fairness of the company's leaders and the treatment of employees.
Tags
Clinical Research, Epidemiology , Pharamcovilgiance, Clinical Data Management, Biostatistics , Regulatory, Clinical Trials, Post-Market Survelliance, Clinical Data, Database Design, Analysis, Medical Writing, Clinical Project Management, Clinical Study Management, Pharmacoepidemiology, Patient Safety, SAS, SPSS, Clinical Operations
Information about Cook Medical/Med Institute, Inc.
Company Rank: Not Available
Average length of employment : 5 years
Average salary of employees: $64,000
These are some of the questions we asked our climbers about their experiences with Cook Medical/Med Institute, Inc.:
| 05| | ||
| Were your performance expectations clearly communicated? | 0.0 |
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| Were you recognized for meeting or exceeding expectations? | 0.0 |
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| Did you feel like your personal contribution was important? | 0.0 |
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| Was your career path clearly outlined and discussed? | 0.0 |
| 03| | ||
| I would recommend this as a place of employment. | 0.0 | |
| I believe in the purpose of this organization. | 0.0 | |
| I would work for this organization again. | 0.0 | |
| I feel employees are fairly compensated. | 0.0 |
Climbers who worked at Cook Medical/Med Institute, Inc. had these interests:
| Websites | |
|---|---|
| American Statistical Association http://www.amstat.org |
The American Statistical Association is the world’s largest community of statisticians. |
| Society of Healthcare Epidemiology of America http://www.shea-online.org |
Define best practices in healthcare epidemiology worldwide |
| Society of Clinical Research Professionals http://www.socra.org |
A professional membership organization, was developed to provide educational programs, certification, and a forum for research professionals to exchange information |
| Society of Clinical Data Management http://www.socra.org |
To support Clinical Data Management professionals |
| US Food and Drug Adminstration http://www.fda.gov |
FDA |
| American Management Association http://www.amanet.org |
An international leader in management training and professional development for individuals, teams and entire company |
