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Clinical Research Associate

System One

Church

Remote

GBP 60,000 - 80,000

Full time

30+ days ago

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Job summary

An established industry player is seeking a Clinical Research Associate for a fully remote opportunity. This role is pivotal in managing the clinical monitoring process, ensuring adherence to regulatory requirements and company SOPs. The ideal candidate will have over five years of clinical monitoring experience, particularly in oncology, and a strong grasp of ICH/GCP Guidelines. This position offers the chance to work on impactful clinical trials, coordinating activities to meet timelines and metrics. If you are passionate about clinical research and ready to make a difference, this role is for you.

Qualifications

  • 5+ years in clinical monitoring, especially in oncology.
  • Strong knowledge of ICH/GCP Guidelines and regulatory requirements.

Responsibilities

  • Manage clinical monitoring to ensure site compliance with regulations.
  • Coordinate interim and closeout activities for clinical trials.

Skills

Medical Terminology
Clinical Trial Process
Regulatory Requirements
Oncology Knowledge
ICH/GCP Guidelines
EDC Process
Interpersonal Skills

Job description

Clinical Research Associate

Location: Remote - fully remote opportunity, Bethesda, MD area (candidates within a 3 hour drive or easy / short plane ride to DC and Northern, VA may also be considered). All site visits will be in Bethesda, MD location.

Start Date: 03/31/2025
End Date: 07/30/2025 (extension possible)


JOB DESCRIPTION:

Summary:

Assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of interim and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study. This is a contract traveling CRA position if necessary.


Knowledge, Skills and Abilities:
  • Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs.
  • Good knowledge of therapeutic area assigned; oncology.
  • Preferred experience working with NCI.
  • Strong knowledge of ICH/GCP Guidelines and EDC process.
  • Ability to establish rapport with site personnel/colleagues.

Experience:
  • 5+ years in clinical monitoring, in particular oncology therapeutic experience.

Ref: #568-Clinical

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