Clinical Research Associate

1. Clinical Study Documentation: - Filing and maintaining CRFs, subject diaries, and other subject-specific documentation. - Develop study-specific annotated CRFs, database documentation, edit check specifications, data handling conventions, and data entry instructions.

2. Database Management: - Ensure each clinical study database is designed in accordance with the database definitions outlined in the DMP. - Perform Electronic Data Capture using databases Medidata RAVE and Oracle clinical.

3. Data Analysis: - Review, extract, compile, and analyze patient data such as coded financial and medical records. - Reconcile device issues, adverse events, and serious adverse events. - Validate results and conclusions from experiments and data from research for use in clinical business intelligence systems.

4. Compliance and Quality Assurance: - Implement study-specific procedures to ensure compliance with regulations and internal best practices. - Oversee external and internal data management activities and modify the system to serve new purposes and improve workflow.

5. Reporting and Communication: - Prepare reports and communicate results to Management, Stakeholders, and coordinate with other relevant departments for areas to be analyzed.

6. Collaboration: - Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Drug Safety and Pharmacovigilance; CROs, central and local laboratories, and other vendors.

7. System Development: - Analyze future and current end-user requirements to improve clinical operations. - Develop and analyze systems for obtaining statistics from research projects. - Create mechanisms for approving and distributing information.

8. Project Management: - Hold periodic conferences with project personnel to review work plans and individual responsibility. - Review technical correspondence with contractors/sponsors to check technical accuracy and promptness of payments. - Ensure budgetary goals are met and that all work is performed in a timely and cost-effective manner. - Identify necessary resources, develop plans for data-related projects, and determine timelines and milestones. - Coordinate and complete data management activities to meet project timelines.