Clinical Research Associate

1 month ago


Trenton, United States GForce Life Sciences Full time

CRA

Duration: 12-month contract

Location: Remote in Princeton, NJ - requires 50% travel


Responsibilities:

  • Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions.
  • Ensures validity of study by identifying/resolving discrepancies and obtaining missing data and may track core lab activities and more complex components of the trial.
  • Contributes to developing and writing clinical protocols, case report forms, and other study aids for investigational products by addressing issues by interacting with appropriate personnel.
  • Maintains expertise in regulations for applicable geographies and types of studies (IDE, non­ significant risk, feasibility, exempt, etc.). Serves as a resource related to clinical trial regulations.
  • Serves as a trainer for contract research organizations (CROs) needed for additional monitoring support.


Qualifications:

  • Bachelor's degree in a related field
  • Multi-site data monitoring experience, covering all visit types ~evenly is needed in a US site and good understanding of US regulations.
  • Experience creating and reviewing clinical documents such as training materials for SIVs, protocols, CRFs, ICFs, brochures.
  • Participation in Data Management activities like UAT (user acceptance testing) and Study Reviews.
  • Minimum one-year Clinical Research Exp from the Sponsor side.
  • 3 - 6 years of experience in a clinical environment with Medical Device and/or IVD experience.


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