In House CRA

Remote in Jacksonville, FL, US • Posted 8 hours ago • Updated 8 hours ago

Contract W2

On-site

Fitment

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Job Details

Skills

Google Cloud Platform
Google Cloud
Management
Recruiting
Documentation
Reporting
Forms
Organizational Skills
Training
Optimization
Clinical Trials
Medical Devices
Research
Pharmaceutics
Clinical Research
EDC
Communication

Summary

In-House Clinical Research Associate I

Summary:
The In-House CRA I is based in the client's facility and will provide clinical research support and assistance in overseeing the conduct of clinical trials.

Responsibilities:

Work to ensure that trials are adhere to study protocols, applicable SOPs, FDA regulations, International Conference for Harmonization (ICH) / Good Clinical Practices (Google Cloud Platform) guidelines, and government regulations.
Evaluate, monitor, and document study results.
Exercise good clinical judgment and demonstrate professional conduct when interacting with investigational site personnel and sponsor representatives.
Monitor Clinical Research Organizations (CROs) and study management of multiple sites.
Additional duties include: document retrieval, archival, informed consent release forms, amendments, etc.
Responsible for the management of designated clinical trials including investigator recruitment and selection, analysis of potential patient recruitment, preparation of trial related documentation (protocols, case report forms, investigators brochures, consent documents, letters of agreement, confidentiality agreements), organizing Ethics committee submissions with follow through to ensure successful outcome, investigator and study staff training.
Ensure procedures are in place for appropriate optimization of patients into the clinical trial.
Planning the requirements for clinical trial material (CTM), ordering CTM, setting up and monitoring the systems whereby the CRA can ship CTM to the investigator, maintaining procedures to account for the CTM, checking the expiration of CTM, and requesting extensions if necessary.
Approximately 15% local on-site co-monitoring

Qualifications:
Bachelor's degree required
1-3 years combined experience with at least one of the following:
Medical device research experience
In-house pharma CRA experience (strictly Regional CRA experience will be considered)
Clinical Research Coordinator (site-level Study Coordinator) experience is required in lieu of CRA experience
On-site monitoring experience is preferred but not required
Electronic Data Capture (EDC) experience required (non-discriminatory)
Excellent oral and written communication skills

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10105282
Position Id: 868999
Posted 8 hours ago

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