Senior Clinical Research Associate
20 ore fa
Senior Clinical Research Associate (Oncology)
Working embedded with a leading global oncology-focused biopharmaceutical company
We are partnering with a top-tier global biopharmaceutical organisation to support a growing oncology portfolio and are seeking an experienced Clinical Research Associate to join the team in an advanced, hands-on clinical role.
This position offers the opportunity to work closely with a sponsor team, supporting Phase I–III oncology studies (liquid and solid tumours) and contributing across the full clinical trial lifecycle.
Key Responsibilities
Conduct routine site monitoring visits and support site selection, initiation, and close-out activities
Ensure clinical trials are conducted in accordance with GCP, ICH guidelines, approved protocols, SOPs, and regulatory requirements
Serve as the primary point of contact for investigators, site staff, CROs, and vendors
Support feasibility assessments and site selection in collaboration with the study team
Assist with the development and review of clinical documentation in including protocols, informed consent forms, monitoring plans, CRFs, and data management plans
Support and manage patient recruitment strategies to increase enrollment and randomisation
Review AEs and SAEs, ensuring appropriate documentation, follow-up, and communication of safety issues
Support data review, validation, and cleaning activities to meet study timelines
Order and coordinate study supplies
Develop and maintain tracking tools to support clinical trial oversight
Plan and participate in investigator meetings and CRA trainings
Participate in co-monitoring activities with CRO CRAs as required
Provide guidance and support to junior CRAs as part of the wider study team
Requirements
Bachelor's degree or Registered Nurse qualification, preferably in Life Sciences
Minimum of 5 years' experience as a Clinical Research Associate within the pharmaceutical or biotechnology industry
Experience in monitoring clinical trials from start-up through database lock
Strong oncology monitoring experience across Phase I–III trials, including liquid and solid tumours
Strong knowledge of GCP, ICH, and applicable regulatory requirements
Ability to work independently while collaborating closely with the sponsor and cross-functional teams
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