Trial Management Professional
hace 6 días
**Job Function Summary**
Fundacion De Estudios Clinicos is seeking a highly skilled Clinical Research Coordinator to manage day-to-day operations of clinical research studies. The ideal candidate will have excellent organizational and communication skills, with ability to collaborate with research teams and ensure compliance with protocols.
About the Job Requirements:**
- 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 Ideal Candidate:**
- 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.
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