Clinical Research Associate

Job Description

:

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, eg. 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 Screening and identifying business and product-relevant scientific literature as assigned

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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

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

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