This position will provide comprehensive support to the research team by assisting with research project activities, coordination, documentation, and administrative processes. This position will work with and be the primary person to manage our clinical trials programs and provide regulatory support.
Preferred Skills: Seeking a person experienced in human research studies, with the ability and experience to train research staff on how to manage clinical trials. This is a working leadership role in the Institute for Stroke and Cerebrovascular Disease with the expectations that the person will have good knowledge on research compliance, has experience in audits for clinical trial studies and is capable of leading internal audits on the studies. Experience with CAPA plans and being able to oversee day-to-day activities and is knowledgeable and have the ability to find resources for questions that come up from research staff. This role will be expected to assist with writing research protocols as well as be the lead in writing RFA's for pilot studies and manage the administrative components of those pilot studies.
*This is not a research administrators (pre/Post award) position.
Position Summary:Manages subject recruitment, site development, enrollment of human subjects and clinical trial monitoring.
Position Key Accountabilities:- Manages all aspects of the clinical trial including but not limited to budget development, budget negotiation, coverage analysis development, contracts, regulatory compliance, and pre and post award activities.
- Identifies and evaluates programs, companies, universities/colleges, etc., where large populations of potential subjects reside.
- Identifies, develops, and maintains suitable site(s) for on-going trial visits.
- Develops and implements presentations/recruiting initiatives for clinical trials including presenting to potential trial subjects.
- Maintains regular communication with clinical sites, investigators, subcontractors, and/or pharmaceutical companies.
- Manages collaboration with all principal investigators to implement processes and structure for conducting clinical trials by institutional guidelines. Interacts with project teams and provide required/necessary training.
- Creates annual budget, negotiate with service contracts, and reports on progress and authorizes expenditures.
- Oversees and assigns responsibilities, monitors progress of the clinical trials, and provides supervision and education to research personnel, nurses and principal investigators.
- Manages Human Resources activities of department in regards to: recruiting and selection, hiring and termination, training, professional development, mentoring, counseling, performance evaluations, and salary planning.
- Performs other duties as assigned.
Certification/Skills:- Bilingual-English/Spanish preferred
- Manages Human Resources activities of department in regards to: recruiting and selection, hiring and termination, training, professional development, mentoring, counseling, performance evaluations, and salary planning.
- Registered Nurse (RN) State Licensure or Nurse Licensure Compact (NLC) by Texas Board of Nursing (BON) depending on clinical trial may be required
- Human Subjects Research (HSR) by Collaborative Institutional Training Initiative (CITI Program) may be required
Minimum Education:Bachelor's Degree required In the event that an RN degree is required, Bachelor's degree may be waived
Minimum Experience:7 years of relevant experience required Pharmaceutical or clinical research strongly preferred
Physical Requirements:Exerts up to 100 pounds of force occasionally and/or up to 50 pounds frequently and/or up to 20 pounds 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.
