We want to expand our team and we are looking for a freelance Clinical Research Associate-Europe.
This position is responsible for study site management from site selection to initiation until monitoring and close-out of assigned clinical studies.
We are looking for someone who demonstrates:
- Intense collaboration;
- Passionate customer focus;
- Tenacious commitment to continuous improvement;
- Relentless drive to win.
Here is a glimpse of what you’ll do:
- Study site selection, initiation (SIV), clinical monitoring and close down according to GCP, protocol and monitoring plan.
- Perform pre-study visits to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.
- Support collection of sites specific EC/CA submission documents.
- Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.
- Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in the protocol, SOP, ICH GCP and GCP.
- Track study recruitment to ensure recruitment target is achieved in all studies.
- Conduct monitoring visit according to SDV plan; address issues with sites and complete monitoring visit report in a timely manner coordinating.
Specific Job Duties:
- Oversees the progress of a clinical investigation and makes sure it is performed, registered and reported according to the protocol, to the standard operating procedures (SOPs), to the Good Clinical Practice (GCP) and the available law requirements;
- Ensures compliance with the clinical investigation protocol, verifies clinical activities in sites, performs site visits;
- Ensures the protection of rights, safety and wellbeing of the subjects enrolled in studies; ensures the reported data is correct, complete and verifiable; ensures that adverse events are correctly documented and reported.
- A Bachelor’s degree or equivalent in Medicine, Pharmacy or Engineering (Organic Chemistry, Biochemistry, Biotechnology);
- Advanced knowledge of the English language. Other languages represent an advantage;
- At least 3-5 years experience in a similar job;
- Willing to travel for professional purposes.
What we offer:
- A dynamic working environment in a growing international company;
- Opportunity for professional development.