Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. This is a work from home position that requires travel. Company credit card for business purposes
A (Senior) Clinical Research Associate is acting as the primary contact and responsible for conducting monitoring activities at a clinical site(s) for a clinical trial(s) and will be assigned clinical monitoring activities in a single country or in several countries ensuring quality service and appropriate clinical study conduct, ensure subject safety and verify diligence in protecting the confidentiality of each subject.
Guarantee the adequacy, the reliability and quality of the data collected from sites and shall participate in the quality control processes to ensure the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with any applicable regulatory requirements in the assigned countries.
Complete project-specific and other job-related trainings and attend client meetings as needed for the clinical trial
Perform source document verification, source data review, review regulatory documents and investigational product, and prepare monitoring visit reports, including confirmation and follow-up letter, as outlined in the Monitoring Plan
Ensures training compliance of site staff
Support the submission to via the CTIS portal and where applicable to the and when applicable to Competent/Regulatory Authorities
Conduct different types of monitoring visits (pre-study visits, site initiation visits, interim monitoring visits & close out visits)
The ideal candidate should have as a minimum a Bachelor’s degree; The ability to perform travel up to an average of 80%, depending on project needs
~ The candidate must have excellent verbal and written communications skills; You must be fluent in German as well as written and oral in English (any additional languages would be appreciated).
It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.
This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job.