CTO Clinical Research Assistant- Senior (MCC)

Under limited supervision, the Clinical Research Assistant – Senior 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. The Senior will assist the lower-level Research Assistants by reviewing their work and training as needed.

• 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.
• Educates staff on proper source documentation practices and addresses discrepancies to maintain data integrity.
• Maintains confidentiality of patient information and 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.
• Independently verifies that all entered data are supported by source documentation and participates in quality control activities to maintain data integrity.
• Conducts peer reviews of source documentation prior to Quality Assurance review.
• Trains staff on creation of source documentation.
• Assists with troubleshooting data entry issues, responding to database and sponsor queries, and entering serious adverse event (SAE) data as required.
• Reviews the work of Associate and Intermediate-level assistants, offering guidance whenever necessary.

• 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.
• Advanced knowledge of medical terminology and clinical documentation practices.
• Strong understanding of Institutional Review Board (IRB) requirements and ethical standards in clinical research.
• Advanced knowledge of HIPAA regulations, confidentiality standards, and institutional clinical research policies.
• Expert understanding of basic biostatistics and clinical data interpretation.
• Strong attention to detail and data accuracy.
• Excellent organizational and time management skills.
• Advanced skill in using Microsoft Office Suite (Word, Excel, Outlook) and database systems.
• Proven ability to interact professionally with patients, sponsors, monitors, and staff.
• Expert written and verbal communication skills.
• Advanced knowledge of standard clinical research practices, oncology care procedures, and data management principles.
• Ability to train, motivate and review the work of lower-level counterparts.

Education:

Bachelor's degree is required.

Experience:

Two (2) to Three (3) years of related experience is required.