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

　　#IND456

　　#LI-EU1

　　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.

　　Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care.

　　Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com .