CTO Clinical Research Assistant, Associate

Key Responsibilities

• Enter patient data from clinical trials into sponsor or local databases accurately and promptly.
• Locate required information in patient records and ensure data accuracy and integrity.
• Collaborate with the research team to resolve data queries.
• Coordinate monitoring visits with study monitors.
• Participate in study teleconferences with sponsors and clinical research organizations.
• Ensure accurate, complete, and compliant documentation of patient encounters and study data in the medical record and research files.
• Obtain required external records and laboratory results for research purposes.
• Address data discrepancies with clinicians and research team members.
• Maintain confidentiality of patient information.
• Participate in developing approved source documents and templates.
• Adhere to Mays Cancer Center and sponsor data management plans.
• Ensure timely, accurate entry of source data into case report forms (CRFs) and electronic databases.
• Verify that all entered data are supported by source documentation.
• Participate in quality control activities to maintain data integrity.
• Assist with troubleshooting data entry issues.
• Respond to database and sponsor queries.
• Enter serious adverse event (SAE) data as required.

Requirements & Tech Stack

• Microsoft Office Suite (Word, Excel, Outlook)
• Database systems

Qualifications

• 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.
• 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.
• No prior experience required.