Clinical Research Associate II, Phase I - California
$100 - $120 K
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L4
$100 - $120 K
Industries
Other Scientific and Technical Consulting ServicesResearch and Development in the Physical, Engineering, and Life SciencesAll Other Outpatient Care Centers- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
- Responsible for all aspects of site management as prescribed in the project plans
- General On-Site Monitoring
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data
- Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested
- Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEsIndependently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
- Assist with training of new employees, eg. co-monitoring
- Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned
- Perform other duties as assigned by management
Level
MidL4
Salary
$100 - $120 K
Location
Denver, CO
Occupation
Clinical Research Coordinators
Industry
Other Scientific and Technical Consulting Services
Posted
yesterday
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