* Location: Neuchâtel, Switzerland (on-site)
* Commencement: 1st of June or later
* Languages Required: Fluent English, French and German (spoken and written)
About the Role:
We are seeking an experienced and motivated Senior Clinical Research Associate (Senior CRA) to join our clinical operations team in Neuchâtel. This role is designed for a clinical research professional with a strong understanding of the Swiss environment, capable of contributing to the operational management of clinical studies from start-up to close-out across all trial phases in different therapeutic areas. The Senior CRA will also be responsible for on-site monitoring activities, ensuring compliance with ICH-GCP, study protocols, and applicable regulations. The role requires strong communication skills, excellent documentation abilities, and the capacity to build and maintain strong relationships with investigational sites and sponsors, ensuring that studies are conducted efficiently.
Key Responsibilities:
* Contribute to the planning and execution of clinical studies across all phases of the trial lifecycle in Switzerland (medicinal products)
* Support feasibility, site selection, and study start-up activities, including preparation of regulatory and ethics submissions
* Perform on-site monitoring activities including site initiation, routine monitoring, and close-out visits
* Ensure clinical trial conduct complies with study protocols, ICH-GCP, SOPs, and regulatory requirements
* Review source data, CRFs/eCRFs, and essential documentation to ensure data integrity and quality
* Write, review, and maintain high-quality clinical trial documentation (monitoring reports, follow-up letters, study correspondence, etc.)
* Maintain strong, professional relationships with investigational site staff and sponsors
* Identify, document, and follow up on issues, deviations, and corrective and preventive actions (CAPA)
* Contribute to continuous improvement of monitoring processes and other internal processes
* Support regulatory submissions and approvals (e.g., ethics committee submissions, amendments, and notifications), as required
* Act as a key point of contact between investigational sites, sponsors, and internal teams
* Coordinate site-related activities, including operational aspects of site contracts and agreements
* Contribute to the review of study documents, including protocols, informed consent forms, and essential documents
* Maintain study tracking, reporting, and continuous improvement of clinical and operational processes
Requirements:
* Degree in Life Sciences, Pharmacy, or a related field
* At least 8 to 10 years as a Clinical Research Associate (or similar clinical research role)
* Strong knowledge of ICH-GCP and clinical trial local applicable regulations
* Proven familiarity with the Swiss clinical trial environment and investigational site network
* Proven ability to write clear, accurate, and compliant clinical documentation
* Ability to manage study activities independently and prioritize effectively
* Strong interpersonal and communication skills
* Experience with early-phase clinical trials
* Exposure to decentralized or hybrid clinical trial approaches as well as modern trials
* Contribution to protocol development, study design, or scientific documentation
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