What are the responsibilities and job description for the Clinical Data Coordinator position at Katalyst CRO?
Responsibilities
- Collect, enter, and manage clinical trial data using electronic data capture (EDC) systems.
- Perform data validation and query management to ensure data quality and compliance with study protocols.
- Assist in the development of case report forms (CRFs) and data management plans (DMPs).
- Conduct ongoing data review and discrepancy resolution in collaboration with clinical staff.
- Generate data listings and summaries for interim and final study reports.
- Ensure data handling is in compliance with GCP, ICH guidelines, and applicable regulatory requirements.
- Maintain study documentation, audit trails, and data queries logs.
- Participate in cross-functional study team meetings and contribute to project timelines.
- Bachelor's degree in life sciences, healthcare, information technology, or related field.
- 1 3 years of experience in clinical data management or a related clinical research role.
- Familiarity with EDC systems (e.g., Medidata Rave, Oracle Clinical, REDCap).
- Knowledge of GCP, ICH, and regulatory guidelines.
- Excellent attention to detail, organizational, and communication skills.
- Proficiency in Microsoft Excel and other data management tools.