Summary

The Texas Children's Cancer and Hematology Centers (TXCH) Senior Research Coordinator is responsible for implementation and coordination of all aspects of clinical trial activities for multi-site and local studies. Implements, coordinates and manages multisite projects and serves as the liaison between the outside sites and the coordinating center. The Senior Research Coordinator will perform clinical research duties requiring critical thinking skills and high-level knowledge of study protocols.

Job Duties

• Interviews, screens and recruits patients for therapeutic and non-therapeutic studies; perform the subject consent process for biology, procurement and registry studies; explain process and procedures to educate participant regarding the research study.
• Collaborates with study team and physicians to assist in determining patient eligibility for research protocols. Collect patient information through direct patient interviews, questionnaires and chart abstractions; process documents and enters information into databases or case report forms.
• Collects, processes, ships, and maintains paperwork for blood and/or biological specimens according to procedures outlined in study protocol and SOPs.
• Maintains study records and regulatory documents for research studies.
• Schedules research participant for tests and procedures such as laboratory tests, x-rays, and other studies specific for the research protocol; retrieve and submit test results to appropriate party.
• Orders supplies and equipment. Accountable for accurate research order entry into Epic Beacon/review of orders with providers to ensure everything has been entered correctly and confirms that they were indeed collected.
• Coordinate Site Monitoring visits with protocol sponsor, study team, regulatory department, investigational pharmacy, and Principal Investigator. Work directly with multiple departments to coordinate diagnostic procedures.
• Facilitates the study start up process, including: Draft multiple study documents to initiate the study start up process (ex. create a Manual of Operations for all protocols, complete the application to use the CRC unit; prepare the RTSS Service Form which outlines all research sample requirements for the study, etc.)
• Organize and set up Site Selection and Site Initiation Visits – work with outside monitors and coordinate schedules with various departments around the institution.
• Conducts initial study training/orientation and ongoing education to physicians and nurses.
• Prepares for and participates in site visits made by sponsor and other entities.
• Recognizes, tracks and assists with reporting adverse events. Facilitates quality assurance and quality control activities for internal and external monitoring.
• Precepts new clinical research staff. Adheres to departmental guidelines and workflows.
• Upholds GCP guidelines. Prepares study-specific reports and queries for investigators and administrators.
• Effectively prioritizes and manages work activities according to study protocol.
• Consults with team members to ensure study time-points are met.
• Volunteers to assist team with overflow duties. Seeks guidance from Clinical Research Manager for additional assignments.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.