CTO Clinical Research Assistant- Associate

Under direct Supervision, the Clinical Research Assistant – Associate is responsible for accurately and promptly entering patient data from clinical trials into sponsor or local databases. They must locate the required information in patient records, ensure data accuracy and integrity, and collaborate with the research team to resolve data queries. Additionally, they coordinate monitoring visits with study monitors and participate in study teleconferences with sponsors and clinical research organizations to maintain consistent communication and information flow.

• Ensures accurate, complete, and compliant documentation of patient encounters and study data in the medical record and research files.
• Obtains required external records and laboratory results for research purposes.
• Addresses data discrepancies with clinicians and research team members to maintain data integrity.
• Maintains confidentiality of patient information participates in developing approved source documents and templates.
• Adheres to Mays Cancer Center and sponsor data management plans, ensuring timely, accurate entry of source data into case report forms (CRFs) and electronic databases.
• Verifies that all entered data are supported by source documentation and participates in quality control activities to maintain data integrity.
• Assists with troubleshooting data entry issues, responding to database and sponsor queries, and entering serious adverse event (SAE) data as required.

Education: Bachelors degree is required.

• Ability to communicate and liaise with research participants, research team members, and other relevant partner/key stakeholders.
• Demonstrated ability to organize and coordinate work within schedule constraints and handle emergent requirements in a timely manner.
• Demonstrated ability to monitor important and complex projects concurrently.
• Familiarity with medical terminology and clinical documentation practices.
• Understanding of basic biostatistics and clinical data interpretation.
• Strong attention to detail and data accuracy.
• Excellent organizational and time management skills.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook) and database systems.
• Ability to interact professionally with patients, sponsors, monitors, and staff.
• Effective written and verbal communication skills.
• Demonstrated knowledge of standard clinical research practices, oncology care procedures, and data management principles.