- To design, implement, and maintain clinical-based relational database management systems and tools.
- To develop methods for tracking and reporting data and monitors incoming and outgoing data to ensure data integrity and compliance with applicable regulatory agency standards.
- To perform a variety of statistical analyses and summarizes results.
- To manage clinical data warehouse systems and reporting to national data marts to ensure accuracy, security, and compliance.
- Ensures operation and maintenance of departmental systems for data organization, collection, retrieval, and reporting purposes.
- Researches and collects information, enters data into established external data marts specific to clinical discipline, and retrieves as necessary.
- Prepares ad hoc or recurring reports for publication or presentation on a periodic basis or as needed.
- Conducts literature reviews.
- Creates data entry instructions and trains data entry personnel.
- Assesses and determines solutions for operational shortcomings of data procurement in protocol design.
- Tracks study progress to report to Principal Investigator(s), sponsor(s), and internal and external collaborators regarding study progress/activities and may perform a variety of statistical analyses and summarize results.
- Assists with the preparation of study reports, manuals, and regulatory submissions (IRB).
- Assists colleagues in identifying efficiencies and improving processes.
- Perform other duties as assigned.
- Comprehensive understanding of related scientific and clinical terminology
- Organizational skills
- Interpersonal skills
- Ability to problem-solve
- Functional expertise in clinical and scientific environments
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Clinical Research Data Coordinator III - University, United States - University of Alabama at Birmingham
Description
Position Summary
Clinical Research Data Coordinator III (CRDC III) will conduct research study activities, with oversight from the Program Manager and Principal Investigator(s), in accordance with the protocol, IRB regulations, and Good Clinical Practice (GCP).
This individual will perform procedures as required by the protocol, including design, implementation, and maintenance of clinical-based relational database management systems.
The CRDC III will ensure the operation and maintenance of departmental systems for data organization, collection, retrieval, and reporting purposes.
They will develop methods for tracking and reporting data and monitoring incoming and outgoing data to ensure data integrity and compliance with applicable regulatory agency policy.
CRDC III will take part in the development of scientific reports and publications and will be a liaison between faculty, CRDC II, other study personnel, and data entry personnel.
The CRDC III will perform statistical analyses, including summarizing results and presenting them to the research team.The CRDC III will attend all study meetings, assist with the preparation of study reports, and perform other duties, as assigned.
General ResponsibilitiesQualifications
Bachelor's degree in a related field and five (5) years of related experience required. Work experience may NOT substitute for education requirement. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred.
Preferred Qualifications
