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Senior clinical research associate

Advanced Clinical
Clinical Research Associate
Inserat online seit: 26 Januar
Beschreibung

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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