Clinical Research Associate
vor 1 Monat
We are seeking a highly skilled and experienced Clinical Research Associate to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for ensuring the smooth execution of clinical trials, from site initiation to close-out.
Key Responsibilities- Conduct site initiation, monitoring, and close-out visits to ensure compliance with Good Clinical Practice (GCP) and regulatory requirements.
- Review and verify site documentation, including informed consent forms, case report forms, and study protocols.
- Collaborate with site staff to resolve issues and ensure timely completion of study activities.
- Develop and maintain strong relationships with site investigators, research coordinators, and other stakeholders.
- Participate in the development and implementation of clinical trial protocols, including study design, patient recruitment, and data management.
- Contribute to the development and maintenance of clinical trial documentation, including study protocols, informed consent forms, and case report forms.
- Ensure compliance with regulatory requirements, including ICH-GCP, 21 CFR Part 11, and other relevant regulations.
- Collaborate with cross-functional teams, including clinical operations, data management, and regulatory affairs.
- At least 5 years of experience in clinical research, including experience in clinical trials management, site monitoring, and regulatory compliance.
- Relevant life science degree or healthcare background, with a strong understanding of clinical research principles and regulatory requirements.
- Excellent communication and interpersonal skills, with the ability to work effectively with site staff, investigators, and other stakeholders.
- Strong analytical and problem-solving skills, with the ability to identify and resolve issues in a timely and effective manner.
- Proficiency in Microsoft Office, including Word, Excel, and PowerPoint.
- Ability to travel up to 8 days per month, depending on project needs.
- Competitive salary and benefits package.
- Opportunities for professional growth and development, including training and mentorship programs.
- Collaborative and dynamic work environment, with a team of experienced professionals.
- Flexible working hours and remote work options, depending on location.
- Access to cutting-edge technology and tools, including electronic data capture systems and clinical trial management software.
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