Job Description
We are seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to join our elite team in Basel. At GlobalMedic Innovations, we are dedicated to accelerating the delivery of life-changing therapies to patients worldwide. If you possess a strong background in clinical trial management, a keen eye for detail, and a passion for improving global health outcomes, we want to hear from you.
As a Senior CRA, you will play a pivotal role in the end-to-end lifecycle of our clinical studies, ensuring compliance with Good Clinical Practice (GCP) and regulatory standards while maintaining the highest level of data integrity.
Why Join Us?
- Work with industry-leading pharmaceutical leaders.
- Comprehensive health and wellness benefits package.
- Professional development and certification support.
- Collaborative and innovative work environment in the heart of Europe.
Responsibilities
- Site Monitoring & Management: Oversee the initiation, execution, and close-out of clinical trials at designated investigative sites to ensure protocol compliance and timely data collection.
- Regulatory Compliance: Ensure that all trial activities adhere to local and international regulatory requirements (EMA, FDA) and Good Clinical Practice (GCP) guidelines.
- Relationship Building: Foster strong, collaborative relationships with Principal Investigators (PIs), study coordinators, and site staff to ensure smooth study operations.
- Quality Assurance: Conduct regular site visits, review source documents and case report forms (CRFs), and identify and resolve any deviations or quality issues promptly.
- Data Integrity: Monitor data entry accuracy and timelines, working closely with the Data Management team to ensure high-quality data submission.
- Reporting: Prepare and submit accurate and timely reports to internal stakeholders and regulatory authorities as required.
Qualifications
- Education: Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Medicine, or related field. Master’s degree is preferred.
- Experience: Minimum of 4-6 years of experience as a Clinical Research Associate in the pharmaceutical or biotechnology sector.
- Certification: Certified Clinical Research Professional (CCRP) or GCP certification is required.
- Language Skills: Fluent in English and German (written and verbal) is essential; French is a plus.
- Technical Proficiency: Advanced knowledge of clinical trial management systems (CTMS) and electronic data capture (EDC) systems (e.g., Oracle ClinicalOne, Medidata Rave).
- Soft Skills: Excellent communication, negotiation, and problem-solving skills with the ability to work independently in a fast-paced environment.