Premier Research
Premier Research is looking for a Senior Clinical Research Associate - FS to join our Functional Services Provider (FSP) team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
What you’ll be doing:
Conducts source verification by comparing data recorded on Case Report Forms against source documents, verifying Informed Consent Forms for accuracy and completeness, and reviewing regulatory documents and device accountability records
Maintains thorough documentation and proper escalation of issues related to visit reports.
Ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with the protocol and applicable regulations.
Supports regulatory inspection activities as required.
Ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
Participates in study-specific meetings, teleconferences and trainings.
Collaborates with cross-functional team members and study sites throughout all study phases.
Manages study contracts, requests/collects relevant investigator/site documentation (i.e. regulatory documents, financial disclosure forms, curriculum vitae/medical license), and reviews and approves documents in applicable database.
What we are looking for:
Bachelor’s degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience
Senior Clinical Research Associate with 5 to 7 years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities. Must be fluent in Dutch & English written and spoken.
Neurology is preferred; however, we can look at candidates who have strong Oncology experience.
Ideally you will be experienced in Phase I in healthy humans (this would be a major plus, Psychiatric and Schedule I experience preferred. This is a great new study focusing on Psychedelics
Knowledge of Controlled substance is preferred, if you do not have this we can put you on a course.
RAVE EDC is nice to have
To start at the end of October or 9th November latest until April 2027.