Senior Clinical Research Associate

  • plaats

    Florida

  • Sectoren:

    Life Sciences

  • soort baan:

    Blijvend

  • salaris:

    Negotiable

  • Contact:

    Carlos Biggemann

  • Contact email:

    Carlos.Biggemann@volt.eu.com

  • functie ref:

    BBBH10881_1658326599

  • gepubliceerd:

    meer dan 1 jaar geleden

  • Vervaldatum:

    2022-08-19

Responsibilities:

Conducting site visits, including pre-study, initiation, monitoring and termination;
Confirming adherence to all FDA, ICH-GCP and local regulations;
Ensuring the completion and collection of regulatory documents;
Performing data verification of source documents;
Ensuring implementation and compliance with FDA, ICH-GCP guidelines;
Participating in budget negotiation and follow-up where applicable;
Assisting with data validation and query resolution;
Mentoring junior team members as required.


Qualifications:

· An advanced level of oncology knowledge

· Minimum 2 years CRA experience

· Completion of a science-related Bachelor's degree

· Excellent knowledge of medical terminology and clinical monitoring process

· Strong ICH-GCPs knowledge

· Experience with clinical trial information systems

· Ability to travel up to 60% on average