home based clinical research associates

1 week ago

London, Greater London, United Kingdom ICON Strategic Solutions Full time
SENIOR CLINICAL RESEARCH ASSOCIATES - ONCOLOGY, HOME BASED, UK

ICON are seeking home based Senior Clinical Research Associates, where you will be assigned to multiple sponsors.

In this role, you are the primary contact point between the sponsor and the investigational site, assigned to trial sites ensuring inspection readiness through compliance with regulatory guidelines and company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP) from start-up through data-base lock.

Your main responsibilities include ;
  • Site / lab assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out.
  • You will partner with the Clinical Trial Assistant (CTA) / Investigator Document Assistant (IDA), Trial Manager (TM) and Global Trial Manager (GTM) to ensure overall site management while performing trial related activities for assigned protocols.
  • Contribute to site level recruitment strategy and contingency planning and implementation
  • Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
  • Ensure accuracy, validity and completeness of data collected at trial sites
  • Responsible for the reporting of all AEs / SAEs / PQCs within the required reporting timelines and documented as appropriate.
  • Maintain complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF / IF, Trial Master Source and Sharepoints).
  • Complete visit reports and follow-up letters to investigators.
  • Responsible for documentation and escalation of major deviations and issues to appropriate stakeholders.
  • Ensures timely corrective actions are completed and documented.
  • Follows the corresponding Monitoring Guidelines for each assigned trial.
This role requires ;
  • A Master degree in Life Sciences, Nursing, or related scientific field is required.
  • A minimum of 3 years of clinical trial monitoring experience is preferred
  • Oncology therapeutic area experience
  • Strong knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
  • Strong IT skills in appropriate software and company systems.
  • Able to travel with occasional / regular overnight stay away from home depending on the region.
  • Ability to work on multiple trials in parallel in different disease areas
If you are seeking the next step in your career, with a competitive salary and benefits package, together with long term development opportunities, please send your CV for review to as soon as possible

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