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clinical research jobs


Clinical Research Associate


There are several roles of the clinical research associate. The first role is to assist the management when it comes to submitting documents and reconciliation. The second role is to participate in the development of the protocol of the hospital. The third role is to prepare and review the regulatory documents, contracts, and the requests for the proposals. The fourth role is to ensure that the CROs and investigators are properly trained on the protocols and any data issues. The fifth role is to review and approve the monitoring reports and ensures issues are tracked.

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Clinical Data Coordinator


There are several roles of the clinical data coordinator. The first role is that they are responsible for reviewing and maintaining the registration compliance information in with accordance to the change control processes. The second role is to receive and enter the registration compliance data into the system. The third role is to review data and determine if there are any new categories or classifications that might be required. The fourth role is that they are responsible for maintaining the keyboard lists in the data entry. The fifth role is to track the data metrics.


Labeling Specialist


There are several roles of the labeling specialist. The first role is to support the required changes of the FDA that might change to apply the serialization to all of the United States packaging of a product. The second role is to create the artwork for packaging for the print in the Abode Create Suite. The person should also be comfortable using Microsoft Word and the electronic artwork management system. The third role is to coordinate all of the changes in the artwork and work the the regulatory managers wile the outstanding work is being produced by labeling specialist.


Clinical Trial Assistant


A clinical trial assistant might have some responsibilities that they do. The first responsibility is to support the clinical trials management and the operational study teams in the delivery of the studies. The second responsibility is to support the study feasibility activities and perform the database searches for the web sites. The third responsibility is organize and maintain the project working files and track the critical documents. The fourth responsibility is to report the discrepancies to the appropriate the clinical team member in a timely manner. The fifth responsibility is to reconcile and transmit all essential documentation.


Regulatory Affairs Manager


A regulatory affairs manager has several responsibilities. The first responsibility is to provide the regulatory guidance throughout the process of research and development. The second responsibility is to act as a point of contact of the regulatory issues in the United States for assigned projects. The third responsibility to act like a liaison for the FDA. The fourth responsibility is to identify and assess the regulatory risks that might be associated with product development and define the strategies that can mitigate the risks. The fifth responsibility is to coordinate all of the aspects of the regulatory submissions.