(Senior) Clinical Research Associate

Overview:

- **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
- Ability to attend a future Ovations Club trip that is directly depended on your performance.
- Wellness reimbursement up to €67/£57 per month for fitness and wellness memberships
- Visibility and recognition by Senior leadership for positive contributions to the business
- Active Incentive Plan
- Pension Scheme as per local requirements
- And more

Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research.

**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 the Independent Ethics Committees (central and local) 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:

- Experience in multiple therapeutic experiences
- 1+ years of on-site monitoring experience required
- The ability to perform travel up to an average of 80%, depending on project needs
- You must be fluent in the language of the territory you are assigned to as well as written and oral English (any additional languages would be appreciated).

It is Advanced Clinicals’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, 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 discuss the appropriate alternatives available.

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