Clinical Data Coordinator I

Summary

Caris Life Sciences is a precision medicine and oncology company focused on improving patient outcomes through molecular science and AI. The Clinical Data Coordinator I collects, reviews, enters, and validates clinical research data for oncology protocols, maintains data quality and documentation, and supports regulatory compliance across investigative sites.

Responsibilities

• Abstract clinical data from subject source documentation
• Enter clinical data into the study specific EDC case report forms
• Clean the clinical data to verify accuracy
• Update the EDC following verification of subject data, including the resolution of data queries
• Track site goals and case report form completion
• Prioritize site cases for analysis
• Maintain study specific documentation
• Perform QC audits of the clinical database
• Support and adhere to Good Clinical Practices (GCP) guidelines, FDA, Institutional Review Board (IRB) and HIPAA regulations, Site Operating Procedures and ethical standards for the conduct of research clinical trials
• Work closely with onsite team to confirm appropriate consenting is being performed and documented prior to data abstraction
• Maintain to Caris and Site requirements for source document management and request for information
• Act as site designated entry person
• Willingness to travel to multiple investigative sites if required
• Communicate effectively with the research team, investigator(s), Clinical Research Associate(s), study sponsor and ancillary staff

Skills

• Position requires 3-5 years of experience in data collection activities within a GCP/clinical research regulatory environment
• Knowledgeable in critical elements for success in clinical trials. GCPs, ICH, and Code of Federal Regulations
• Clinical study experience in the field of Oncology
• Strong medical terminology understanding
• Experience in both small and large scale project planning and reporting with strong communication and presentation skills
• Experience in providing training for both internal and external staff with a mentorship approach for less experienced colleagues
• Experience with EDC systems
• Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use
• Must possess ability to sit and/or stand for long periods of time

Qualifications

Must Haves

• Position requires 3-5 years of experience in data collection activities within a GCP/clinical research regulatory environment
• Knowledgeable in critical elements for success in clinical trials. GCPs, ICH, and Code of Federal Regulations
• Clinical study experience in the field of Oncology
• Strong medical terminology understanding
• Experience in both small and large scale project planning and reporting with strong communication and presentation skills
• Experience in providing training for both internal and external staff with a mentorship approach for less experienced colleagues
• Experience with EDC systems
• Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use
• Must possess ability to sit and/or stand for long periods of time

Benefits

• Highly competitive and inclusive medical, dental and vision coverage options
• Health Savings Account for medical expenses and dependent care expenses
• Flexible Spending Account to pay for certain out-of-pocket expenses
• Paid time off, including: vacation, sick time and holidays
• 401k match and Financial Planning tools
• LTD and STD insurance coverages, as well as voluntary benefit options
• Employee Assistance Program
• Pet Insurance
• Legal Assistance
• Tuition Assistance