CTO Clinical Research Assistant- Senior (MCC)
About The Position
Under limited supervision, the Senior Clinical Research Assistant accurately and promptly enters clinical-trial patient data into sponsor or local databases. The role locates required information in patient records, ensures data accuracy and integrity, and collaborates with the research team to resolve data queries. The position also coordinates monitoring visits with study monitors and participates in study teleconferences with sponsors and clinical research organizations to support consistent communication and information flow. The Senior Clinical Research Assistant supports and reviews the work of lower-level Research Assistants and provides training as needed. The role maintains compliant clinical-trial documentation, supports quality control, and ensures source data is accurately entered and supported by source documentation.
Requirements
- Bachelor's degree required.
- Two to three years of related experience required.
- Ability to communicate and liaise with research participants, research team members, and other relevant partners and stakeholders.
- Ability to organize and coordinate work within schedule constraints and handle emergent requirements in a timely manner.
- 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 Microsoft Office Suite (Word, Excel, Outlook) and database systems.
- 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.
Responsibilities
- Ensure accurate, complete, and compliant documentation of patient encounters and study data in medical records and research files.
- Obtain external records and laboratory results required for research purposes.
- Educate staff on source documentation practices and address discrepancies to maintain data integrity.
- Maintain confidentiality of patient information and participate in developing approved source documents and templates.
- Follow Mays Cancer Center and sponsor data management plans, entering source data promptly and accurately into case report forms (CRFs) and electronic databases.
- Verify that entered data are supported by source documentation and participate in quality-control activities.
- Conduct peer reviews of source documentation before Quality Assurance review.
- Train staff on creating source documentation.
- Troubleshoot data-entry issues, respond to database and sponsor queries, and enter serious adverse event (SAE) data as required.
- Review the work of Associate- and Intermediate-level assistants and provide guidance as needed.
- Coordinate monitoring visits with study monitors and participate in study teleconferences with sponsors and clinical research organizations.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
