Full-Time

Clinical Research Associate II

Florida Based

Posted on 10/25/2024

Fortrea

Fortrea

Biotechnology
Healthcare

Compensation Overview

$100k - $115kAnnually

Mid

Remote in USA

Candidates can be located anywhere in the State of Florida.

Category
Public Health
Biology Lab & Research
Biology & Biotech
Requirements
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
  • 2 years of Clinical Monitoring experience
  • Phase I experience is preferred but not required
Responsibilities
  • 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 SAEs
  • Independently perform CRF review; query generation and resolution against established data review guidelines on Covance 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

Company Stage

N/A

Total Funding

N/A

Headquarters

N/A

Founded

N/A

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