Clinical Data Coordinator -I

Job Overview

Summary Of Responsibilities

• Ensure electronic vendor data contains all protocol specified parameters, is in correct format and data populates to the specified fields and patients correctly.
• May support LDM in the development of the Data Transfer Agreement and Data Transfer Specifications for vendor data transfers.
• Review data discrepancies generated by study-specific edit checks for External data and perform the subsequent query management process in resolving the data issues.
• May support LDM to perform validation review of the electronically transmitted data for a sample of total number of patients in the study for loading purposes.
• Assist with review of External Data edit checks, External Data status reports and External Data listings.
• Interact with Clinical staff (CTM/CRA) to obtain local laboratory normal ranges for all sites. Research and resolve discrepant information concerning the normal ranges and maintain proper documentation.
• Enter and perform QC for local laboratory normal ranges. Verify the normal ranges are properly attached to the patient results in the local lab data collection module of the database.
• May support LDM to communicate to vendors and client problems involving data transfers, data point issues and validation issues with initial oversite for support of this communication from EDS 2 or above.
• All other duties as needed or assigned.
  

Qualifications (Minimum Required)

• University/college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Fluent in English, both written and verbal.
  

Experience (Minimum Required)

• 3 years prior experience in the pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
• Basic understanding of medical terminology a plus.
• Strong organizational, planning, and critical-thinking skills.
• Well-polished, inclusive, and engaging communication skills (written and verbal) to support effective interactions with sponsors and internal colleagues.
• Ability to handle multiple tasks in a timely and professional manner under demanding conditions.
• Ability to use standard Microsoft suite of software products.
• Strong technical aptitude.
• Ability to maintain confidentiality of data and information during interaction with staff at all levels.
• Understanding of ICH-GCP principles.
  

Physical Demands/Work Environment

• Perform in a general or remote office setting.
• Sit for sustained periods of time in front of monitor.
• Perform with multiple interruptions.
• Requires frequent priority adjustment.
• Requires the ability to manage multiple priorities.
• Should be willing to work in flexible shifts as per business requirement.