Clinical Data Coordinator

Role Summary

Responsible for all aspects of Clinical Trial data management from study start-up through database lock and study closure to ensure optimized data collection, ensuring the accuracy and consistency of data for analysis and reporting.

Responsibilities

• Participate in EDC build and User Acceptance Testing, study data cleaning and reconciliation, and database snapshots/locks.
• Assist in developing and maintaining all Data Management documentation, including Data Management Plan, Data Validation Plan, eCRF Completion Instructions. Data Review Plan.
• Collaborate with Study Team members to understand and fulfill data requirements and ensure compliance with study protocol.
• Generate and review data listings, conduct regular quality checks on data, identify discrepancies, create and resolve queries related to data.
• Review and analyze study data metrics, highlighting data trends and issues that may arise during the conduct of the study.

Qualifications

• Required: High school degree/GED and a minimum of 4 years of related experience; or, Associate’s degree in related discipline and a minimum of 2 years of related experience; or, Bachelor’s degree in related discipline; or Equivalent combination of education and experience.
• Preferred: Experience with electronic Clinical Database Systems; Experience with oncology clinical trials.
• Knowledge, Skills And Abilities: Proficiency in database management along with a good understanding of medical terminologies and clinical trial processes; Strong analytical and problem-solving skills to identify and resolve data discrepancies; Excellent written and verbal communication skills to effectively collaborate with team members and stakeholders; Able to follow established SOP.

Education

• High school degree/GED and a minimum of 4 years of related experience; or,
• Associate’s degree in related discipline and a minimum of 2 years of related experience; or,
• Bachelor’s degree in related discipline; or
• Equivalent combination of education and experience.

Skills

• Proficiency in database management along with a good understanding of medical terminologies and clinical trial processes.
• Strong analytical and problem-solving skills to identify and resolve data discrepancies.
• Excellent written and verbal communication skills to effectively collaborate with team members and stakeholders.
• Able to follow established SOP.