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CRA
- Posted: 24/01/2025
- Salary: Competitive
- Location: Remote
- Job Type: Contract
.Opportunity to join a European based Medical Device company, currently going through clinical trials for their implantable device, on a 6-month contract.
Responsibilities:
- Conduct site qualification, initiation, monitoring, and close-out visits for the Class III device clinical trial.
- Assess site performance and ensure that sites are adhering to study protocols and regulatory requirements.
- Provide ongoing support and training to clinical site staff to ensure proper conduct of the trials.
- Ensure accurate and timely collection of clinical data and support in the review and cleaning of data.
- Ensure that clinical trials comply with FDA regulations, international standards (e.g., ISO, GCP), and internal SOPs.
Qualifications:
- 3-5 years of clinical research experience, preferably in the medical device industry.
- Strong knowledge of FDA regulations and ISO standards related to clinical trials.
- Ability to travel up to 70% across the US.