This position is with the Department of Neurosurgery working with the Neuro-Oncology team in the Research Division. The position would lead initiating clinical trials, implementing active trials, contributing to trial finances, and assisting in trial closeouts.
The ideal candidate should have an understanding of brain tumors and experience leading all clinical trials - industry and federal. Working in collaboration with a multidisciplinary team in the Neuro-Oncology team within the Department of Neurosurgery.
Additional duties may include:- Assist the Program Manager and Faculty in the development, implementation, and closure of all Neuro-Oncology Clinical Trials
- Assist in the submission of all IRB protocols, maintain protocols, and ensure compliance in all Neuro-Oncology Clinical Trials.
- Assist the Program Manager in the administrative direction of study personnel.
Position Summary:Under minimal supervision, assists with human subject research project conduct and management, including participant recruitment and data collection, entry, management, and analysis. Assists with research project logistics, maintaining records, preparing reports, and meeting research milestones and deadlines.
Position Key Accountabilities:- Assists with human subjects research activities, including participant recruitment, informed consent, data collection through surveys, interviews, and observations, and ensuring that all activities are conducted according to study protocols.
- Maintains confidential records of collected data, ensures accuracy, compliance and integrity of data. Data may include human subject data and departmental programmatic data. Supports Data Management Sharing (DMS) plan.
- Finalizes annual progress reports and applications for various committees and ensures that all staff have received the proper training/attended the appropriate training courses.
- Assists in the preparation of progress and annual reports, contracts and grant proposals to various funding agencies; works closely with the Office of Sponsored Projects on the submission of grants.
- May assist with regulatory submissions (i.e. Institutional Review Board(s), FDA, etc).
- Assists investigator with quantitative and qualitative data analysis, including statistical tests and the creation of figures, tables, and graphs. Helps prepare research papers, presentations, and reports including manuscripts for publications and conferences.
- Prepares or assists in the preparation of budgets, initiates re-budgeting requests based on the needs of research staff, and authorizes expenditures for multiple projects. Attends research planning meetings to prepare budget drafts for departmental leadership approval. Reconcile and monitor invoices.
- Responsible for coordinating and responding to site monitoring visits, audits, and inspections.
- May be responsible for maintaining study materials (i.e. test kits, investigational drugs and devices).
- May provide administrative direction training and guidance to study personnel within department.
- May provide recommendations by identifying opportunities to enhance, re-terminate, or re-direct resources across various research projects to ensure timely completion of project guidelines.
- Supports complex scheduling and logistical needs to meet projects' expectations.
- Performs other duties as assigned.
Certification/Skills:- Completion of Human Research Subjects training.
- Demonstrated data management skills.
- Excellent communication skills both written and verbal.
- Detailed oriented.
- Work may involve handling biohazardous, chemical, and radiological materials, as well as operating associated equipment. Required safety training and appropriate engineering and administrative controls including the use of personal protective equipment must be followed.
- Health Services\Certified Clinical Research Professional (CCRP) by Society of Clinical Research Associates (SOCRA) preferred
Minimum Education:Bachelor's Degree in a related field required Master’s Degree preferred May substitute required education with equivalent years of experience beyond the minimum experience requirement.
Minimum Experience:5 years of relevant experience required
May substitute required experience with equivalent years of education beyond the minimum education requirement.
Physical Requirements:Exerts up to 20 pounds of force occasionally and/or up to 10 pounds frequently and/or a negligible amount constantly to move objects.
Security Sensitive:This position is a security-sensitive position pursuant to Texas Education Code §51.215 and Texas Government Code §411.094. To the extent that a position requires the holder to research, work on, or have access to critical infrastructure as defined in Texas Business and Commerce Code §117.001(2), the ability to maintain the security or integrity of the infrastructure is a minimum qualification to be hired for and to continue to be employed in that position. Personnel in such positions, and similarly situated state contractors, will be routinely reviewed to determine whether things such as criminal history or continuous connections to the government or political apparatus of a foreign adversary might prevent the applicant, employee, or contractor from being able to maintain the security or integrity of the infrastructure. A foreign adversary is a nation listed in 15 C.F.R. §791.4.
Residency Requirement:Employees must permanently reside and work in the State of Texas.
