Clinical Data Coordinator I

Position Summary

The Clinical Data Coordinator is responsible for clinical data entry activities for the Caris Medical Affairs protocols and projects at the Caris Precision Oncology Alliance sites. The position ensures the highest standards for clinical data integrity and quality are maintained in alignment with critical research efforts aimed to improve the treatment, health, and medical outcomes for oncology patients.

Job 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.
• 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.

Required Qualifications

• 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.