Senior Clinical Research Associate

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. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

***This is a work from home position that requires travel. Senior level is also available depending on experience***

What’s in it for YOU?

• Competitive compensation with paid time off
• Wellness reimbursement up to €48/£40 per month for fitness and wellness memberships
• Visibility and recognition by Senior leadership for positive contributions to the business
• Pension Scheme as per local requirements
• Company credit card for business purposes
• And more!

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.

Responsibilities:

• Follow Protocol(s)/Amendment(s), Standard Operating Procedures (Advanced Clinical or Sponsor SOPs), Good Clinical Practice (ICH GCP), and local regulations per country
• 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
• Reconciliation between the Investigator Site File (ISF) and the Trial Master File (TMF) to ensure audit readiness
• Adhere to monitoring metrics
• Support the submission to via the CTIS portal and where applicable to the and when applicable to Competent/Regulatory Authorities
• Participates to Investigators selection/feasibility process
• Conduct different types of monitoring visits (pre-study visits, site initiation visits, interim monitoring visits & close out visits)
• Develop and maintain site and investigator relationships to ensure clinical trials are managed efficiently

Qualifications:

• The ideal candidate should have as a minimum a Bachelor’s degree; a Registered Nurse (RN) or equivalent may also be considered
• Experience in multiple therapeutic experiences
• years of on-site monitoring experience required (5 for Senior)
• 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; excellent interpersonal and organizational skills with demonstrated attention to detail
• You must be fluent in German as well as written and oral in English (any additional languages would be appreciated).

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

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. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.