We are looking for a highly motivated team member to join our Clinical Operations team in Zurich as a Clinical Research Associate.
Your main responsibilities:
* Support timely delivery of clinical investigation in collaboration with study-assigned Clinical Research Manager (CRM)
* Adhering to required quality standards and laws / regulations
* Independently perform monitoring visits, including site qualification, study site initiation, routine monitoring, and study site closure visits
* Ensure source data verification (SDV) and timely query resolution
* Assists in investigation start-up activities, e.g. Site selection visits and review of regulatory documents
* Establish and maintain regular contact with investigators and the ethics committee as needed
* Prepare and maintain the investigator file, center file, and study master file
* Communicate project-specific information to/from trial sites, document communication with investigation site/teams, and escalate issues to CRM in a timely manner
* Present at and participate in investigator meetings, other study trainings, and meetings as assigned
* Support statistical evaluation of study results within the clinical operations
* Support timely delivery of clinical documentation needed in product development projects, e.g. clinical investigation reports
* Screening and identifying business and product-relevant scientific literature as assigned
Job Requirements:
* A Medical-related scientific degree (e.g. Bachelor, Master, Nursing qualifications)
* Strong knowledge of ISO 14155- GCP and ICH- GCP Guidelines
* Minimum 1-2 years of experience in various clinical trial activities within a medical device industry, preferably dentistry
* Knowledge of the dentistry sector and a strong scientific understanding are preferred
* Good interpersonal skills
* Ability to work both independently and collaboratively within a team
* Fluency in English (reading and writing), any additional language is an advantage
* Strong interest in data analyses, graphing and plotting results, and report writing
* Willingness and ability to travel, as required (25%)
Operating Company: Nobel Biocare
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