LSKB is hiring a Senior Clinical Research Associate
Responsibilities and Duties
Essential Duties & Responsibilities:
- Assist protocol, IB and CRF development
- Provide monitoring guidance
- Plan and assist study start-up activities such as the creation of Site Initiation Presentations, CRF Completion Guidelines and various study tracking and management documents
- Perform pre-site selection, site initiation, interim, close-out and co-monitoring visits
- Provide leadership and professional expertise with consent procedures, protocol compliance, GCP/ICH Guidelines and other applicable regulatory requirements, and assurance of good site performance
- Review and management of monitoring reports and follow-up within project-specific timelines
- Maintain project tracking system of subject and site information
Qualifications and Skills
Experience and Education Required:
- Bachelors level degree in life sciences, pharmacy, nursing or RN preferred.
- 5 years clinical monitoring experience.
- In-depth knowledge of Good Clinical Practice/ICH guidelines.
- Demonstrate leadership abilities.
- Position requires approximately 10% travel (50% during peak times).
- Knowledge of the principles and practices of basic computer applications used in general office settings, including word processing, spreadsheet, database management, and presentation software and Internet search engines.
- Basic math and standard English grammar and usage.
Job Type: Full-time
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