Clinical Research Associate, Entry and Experienced Level
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Job Description
Clinical Research Associate contributing to drug and medical device development at Medpace. Conducting site visits, ensuring compliance, and collaborating with medical teams in Sweden.
Responsibilities:
- Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol
- Communication with the medical site staff including coordinators, clinical research physicians and their site staff
- Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff
- Medical record and research source documentation verification against case report form data
- Ensuring good documentation practices are adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements
- Verification that the investigator is enrolling only eligible subjects
- Regulatory document review
- Medical device and/or investigational product/drug accountability and inventory
- Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
- Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement
- Completion of monitoring reports and follow-up letters, summarizing significant findings, deviations, deficiencies, and recommended actions to secure compliance
Requirements:
- Minimum of a bachelor’s degree; Health or life science related field
- 1 year clinical research experience minimum for Entry level
- 1+ year direct and independent monitoring experience for any level above Entry CRA
- Willing to travel approximately 40-60% in Sweden
- Familiarity with Microsoft® Office
- Strong communication and presentation skills a plus
- Fluent in Swedish and English
Benefits:
- Flexible work environment
- Competitive compensation and benefits package
- Competitive PTO packages
- Structured career paths with opportunities for professional growth
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
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