Summary

The Office of Surgical Research (OSR) within the Michael E. DeBakey Department of Surgery has an immediate opening for a Clinical Research Coordinator III with the Thoracic Surgery Team. This position provides with day to day activities of clinical trials . Many of these duties will include monitoring of research participants, enrollment, and screening. Responsibilities require flexibility and detail oriented individual to work closely with senior research staff. Performs patient screening, blood draws, plans and schedules study visits, does reporting for IRBS, FDA, and Data Safety Review Committee.

Coordinates day to day activities of research protocols which include screening, enrollment, and monitoring of research participants. Ensures accurate data collection, documentation, organization and safety of research participants. May supervise other researc

Job Duties

• Coordinates clinical research activities with clinical care. This involves liaising with physicians from multiple specialties, clinic staff, as well as hospital staff, in order to ensure protocol adherence and conduct the study in accordance with Good Clinical Practices. All of this must be done while simultaneously working to minimize clinic visits, and complete study procedures in a way that they do not interfere with routine clinical care. (20%)
• Comprehensive assessment of adverse events in collaboration with the participant's physician, as well as other care team members, the research coordinator must assess, document, and grade adverse events in accordance with the standardized NCI guidelines. Furthermore, these adverse events must be reported to the sponsor, as appropriate; the research coordinator must have an understanding of which adverse events require modifications (e.g. dose delays, dose modifications, supportive care, etc.), and adequately communicate this to the treating physician and/or care team. (20%)
• Intimate knowledge of multiple study protocols is required to be able to screen, confirm eligibility, and coordinate the necessary battery of tests/procedures without affecting timeline to starting treatment. (10%)
• This position will require for the candidate to serve as a lead coordinator for up to 4 protocols, including screening, enrolling and following patient throughout trial timeline as well as be able to provide cross coverage when needed with other members of the research team. (10%)
• Must be able to balance adherence to protocol requirements/timeline while maintaining an appropriate timeline for lifesaving clinical care within an NCI-designated comprehensive cancer center housed within an academic health science center. (10%)
• Must be able to navigate conflicts in scheduling resulting from departmental conflicts, clinics canceled as a result of COVID or weather, which can then produce a domino effect on treatment timelines, response assessments, etc., and ultimately create difficulties in protocol adherence and timely data collection. (10%)
• This position is the primary point of contact for clinical trial participants. Thus, this individual must be able to discern (in collaboration with departmental physicians) which symptoms are likely related to the investigational product, the disease under study, other medications, or a combination of the above. This individual must be able to obtain the appropriate information from the patient, decide whether or not to escalate it, and then determine its impact on study conduct. (15%)
• Conducts study activities at the Harris Health System and other BCM-affiliated hospitals, as needed. (5%).
• Performs other job duties as assigned.

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

Preferred Qualifications

• Oncology study experience a plus.
• Technical knowledge of REDCap, Microsoft Word, Excel, PowerPoint.
• Bilingual in Spanish a plus.