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Clinical Operations Specialist

2 months ago

Swansea, City and County of Swansea, United Kingdom The Recruitment Co. Full time

Job Title: Clinical Operations Specialist

Job Summary:

The Recruitment Co. is seeking a Clinical Operations Specialist to oversee the progress of clinical and application research/trials. The successful candidate will ensure all research is conducted, recorded, and reported in accordance with Protocols, SOPs, ICH-GCP and applicable regulatory requirements.

Key Responsibilities:

  • Provide a global evaluation of all investigations commissioned and executed.
  • Assist in preparing study documentation for trials, IRB/IEC submissions and documentation for regulatory dossiers.
  • Ensure collection of the required essential documents for study start-up and throughout the conduct of a trial.
  • Conduct on-site training and motivate the investigators.
  • Verify patient data and ensure adherence to protocol, GCP and internal SOPs.
  • Maintain all files pertaining to the clinical trials, track study progress and ensure timely quality updates are provided.

Requirements:

  • Solid degree in scientific subject.
  • Experience in a clinical research setting; proven clinical trial experience.
  • Experience in Phase I-IV trials; Phase II - III is preferred.
  • Working knowledge of EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials Regulations, Principles of ICH-GCP, GDPR and Research Governance Framework Legislation with proven ability to apply these to the coordination of clinical trials.
  • Understanding of current EU Medical Device Regulation.
  • Working knowledge of BS EN ISO 14155 is preferred.
  • Experience working effectively in a team/matrix environment.
  • Proven ability to manage multiple priorities and communicate effectively.

Key Objectives/KPIs:

  • Motivate research team.
  • QA/QC investigators daily activities; ensuring compliance with CIP and regulatory compliance.
  • Ensure research staff achieve targets and deliverables in a timely manner.
  • Conduct detailed audits and trend analysis on key elements of trial execution; bridge the gap.
  • Procure, store, and disseminate study supplies (dispensing and accountability), including investigational devices.
  • Induct, train and mentor new department personnel, including competency testing.
  • Identify and devise new training materials as deemed appropriate.
  • Identify and devise new departmental SOPs/WI and template documentation, as deemed appropriate.