Under the direction of the Associate Director, Clinical Affairs supports the work of the Clinical Reviewer/Clinical Events Committee (CEC) Group of the Clinical Affairs Department in the investigation and documentation of adverse events in multi-center clinical trials conducted both nationally and internationally through the Harvard Clinical Research Institute.
The Clinical Data Coordinator manages the clinical data required for research and trials. This includes running queries, creation and maintenance of clinical reports throughout the study or trial. The Clinical Data Coordinator will manage electronic data to ensure completion and accuracy, as well as adherence to all federal regulations. The successful candidate will perform data management activities to ensure the generation of accurate, complete and consistent clinical data.
Primary Duties and Responsibilities:
• Assists with the implementation and documentation of CEC/Data Safety Monitoring Board (DSMB)-based projects.
• Facilitates distribution of CEC meeting summaries and maintains documentation of the released CEC summaries.
• Facilitates distribution of special CEC adjudication results and maintains documentation of the released CEC results.
• Completes the electronic annotations of the Case Report Form (CRF) according to the specifications provided by the Clinical Reviewers.
• Completes quality assurance assignments.
• Performs database testing and troubleshoots issues with the IT Department.
• Modifies and tests Clinical Review/CEC Department standard queries.
• Under the direction of the Associate Director, Clinical Affairs and/or CEC Operations Associate Supervisor, assists with preparation of data for reports.
• Coordination of additional study tasks, as needed, including communications with Project Managers.
• Preparation of data for DSMB and/or other sponsor reports.
• Maintains and submits study documentation to the electronic central file system.
• Works collaboratively with assigned Clinical Reviewer on the generation and development of various study report specifications.
• Performs other related duties as assigned by the Associate Director, Clinical Affairs and/or CEC Operations Associate Supervisor.
• Bachelor Degree.
• 1-3 years clinical operations experience.
• Individual must be detail-oriented, and have strong data management, sense of urgency, organization and prioritization skills.
• Familiarity with applicable government regulations (FDA, GCP, etc.).
• Must be capable of dealing with periodic cyclical workload pressures and levels of responsibility.
• Must have the adaptability to perform a variety of duties, often changing from one task to another of a different nature without loss of efficiency or composure.
• Advanced proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
• Knowledge in Structured Query Language (SQL).
• Experience with ClinTrial.
• Experience using clinical data management software and/or medical terminology.