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Clinical Study Coordinator Lead
hace 1 semana
**Role Overview**
Fundacion De Estudios Clinicos is seeking an experienced Clinical Research Coordinator to join our team. The successful candidate will be responsible for managing day-to-day operations of clinical research studies, ensuring compliance with protocols, coordinating with research teams, and overseeing patient recruitment and follow-up.
About the Job Description:**
The Clinical Research Coordinator will:
- Manage study start-up activities, including site initiation visits, informed consent form development, and regulatory document submission.
- Collaborate with research teams to ensure timely completion of study milestones and accurate data reporting.
- Develop and maintain comprehensive study files, including regulatory documents, participant information, and adverse event reports.
- Coordinate with sites to ensure compliance with protocol requirements, Good Clinical Practice (GCP), and regulatory guidelines.
- Provide training and support to research staff on study procedures, GCP, and regulatory requirements.
- Maintain accurate records of study-related correspondence, meetings, and actions taken.
About the Skills and Qualifications:**
- Bachelor's degree in a life science or related field.
- At least 2 years of experience in clinical research, preferably in a leadership role.
- Strong organizational and time management skills, with ability to prioritize multiple tasks and meet deadlines.
- Excellent communication and interpersonal skills, with ability to work effectively with cross-functional teams.
- Detailed understanding of GCP, ICH guidelines, and regulatory requirements.
