Katalyst Healthcares & Life Sciences
Clinical Data Coordinator
Katalyst Healthcares & Life Sciences, Boston, Massachusetts, us, 02108
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.
Requirements:
* 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.
* 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.
Requirements:
* 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.