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
Assist 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 investigations 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
Screen and identify 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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