Clinical Research Associate I
2 days ago
Job Title: Clinical Research Associate I
Job Summary:
We are seeking a highly motivated and detail-oriented Clinical Research Associate I to join our team. As a Clinical Research Associate, you will play a crucial role in the planning, execution, and monitoring of clinical trials. You will ensure that studies are conducted in accordance with regulatory requirements, Good Clinical Practice (GCP), and company policies.
Key Responsibilities:
- Study Management: Assist in the design and implementation of clinical study protocols, case report forms, and informed consent documents.
- Site Monitoring: Conduct regular site visits to ensure compliance with study protocols, GCP, and regulatory requirements. Monitor patient recruitment and retention.
- Data Collection & Management: Review and verify data quality and accuracy. Assist in data entry and maintenance of clinical databases.
- Regulatory Compliance: Ensure that all clinical trials are conducted in compliance with local, national, and international regulations. Prepare documentation for regulatory submissions and audits.
- Collaboration: Work closely with investigators, site staff, and cross-functional teams to facilitate smooth study operations and resolve any issues that arise.
- Training: Provide training and support to site staff on study protocols, procedures, and data collection methods.
- Reporting: Prepare regular progress reports and communicate findings to project teams and management.
Requirements:
- Strong analytical skills and attention to detail.
- Ability to work collaboratively with cross-functional teams.
- Excellent communication and interpersonal skills.
- Ability to work in a fast-paced environment and meet deadlines.
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