Freelance Clinical Research Associate
vor 4 Wochen
Freelance Clinical Research Associate - German Region
About the Role:Oxford Global Resources is seeking a highly skilled Freelance Clinical Research Associate to join our team. As a Freelance CRA, you will be responsible for managing clinical activities at study sites conducting medical device studies in the DACH region.
Responsibilities:- Site Management: Ensure human subject protection, GCP, and regulations are followed on assigned studies.
- Monitoring: Coordinate site monitoring responsibilities in accordance with contractual agreements, SOPs, and regulatory guidelines.
- Site Qualification: Conduct on-site and remote site qualification, initiation, interim, and close-out monitoring visits.
- Communication: Serve as primary point of contact for site questions and liaise with study team members as needed.
- Performance Reporting: Communicate site performance, trends, deficiencies, and concerns through verbal and written communication.
- Study Start-Up: Support study start-up activities, including tracking and reviewing study documents.
- Training and Development: Perform study-related training and manage development and maintenance of study documents and systems.
- Quality Assurance: Ensure quality and completeness of central and site master files and tracks study site and overall study metrics.
- Meetings and Progress Reports: Attend internal and external meetings and provide progress reports and visit documentation as required.
- Safety Activities: May support safety activities and prepares and coordinates submissions to regulatory authorities.
- Education: Higher education degree or equivalent education, training, and experience.
- Experience: +2 year's experience as a Clinical Research Associate.
- Industry Knowledge: Experience in monitoring medical device studies.
- Languages: Fluency in English and German.
- Certifications: Certifications such as SoCRA or ACRP Certification preferred but not required.
- Type: Freelance role.
- Duration: 1 year contract to start with (+ possible extension).
- FTE: 0.7 FTE to full-time.
- Travel: Remote working + 80% of travel in Germany, Austria, and Switzerland.
$60,000 - $80,000 per annum, depending on experience.
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