UTHealth Houston
Senior Manager Clinical Trial Program (Stroke Institute)
UTHealth Houston, Houston, Texas, United States, 77246
Stroke Institute, located at 6431 Fannin St., Houston, Texas 77030. Exempt position.
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 (Corrective and Preventative Action) plans and being able to oversee 8 research staff with 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 managing the administrative components of those pilot studies.
The person in this position will need excellent communication skills with study staff, leadership, and sponsors.
Have the ability to bring groups together (both internal and external). This person will not be doing subject recruiting or enrollment but will be managing and training the staff on site development, enrollment of human subjects and clinical trial monitoring. This role will manage multiple studies and be expected to learn and know the SOP’s for each study. This is not a research administrator (pre/post award) position. Confidence, great presentation skills and strong collaborative skills are also required.
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 for direct reports in regards to: recruiting and selection, hiring and termination, training, professional development, mentoring, counseling, performance evaluations, and salary planning.
Other duties as assigned.
Certification/Skills:
Depending on clinical trial, an RN registered in the state of Texas might be required. Depending on clinical trial a Human subjects training certificate might be required. Bilingual–English/Spanish preferred.
Minimum Education:
Bachelor’s degree. In the event that an RN degree is required, the bachelor’s degree may be waived.
Minimum Experience:
Seven (7) years of relevant experience. 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. This position may include work involving potentially hazardous chemical, biological or radioactive agents.
Security Sensitive:
This job class may contain positions that are security sensitive and thereby subject to the provisions of Texas Education Code § 51.215.
Residency Requirement:
Employees must permanently reside and work in the State of Texas.
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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 (Corrective and Preventative Action) plans and being able to oversee 8 research staff with 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 managing the administrative components of those pilot studies.
The person in this position will need excellent communication skills with study staff, leadership, and sponsors.
Have the ability to bring groups together (both internal and external). This person will not be doing subject recruiting or enrollment but will be managing and training the staff on site development, enrollment of human subjects and clinical trial monitoring. This role will manage multiple studies and be expected to learn and know the SOP’s for each study. This is not a research administrator (pre/post award) position. Confidence, great presentation skills and strong collaborative skills are also required.
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 for direct reports in regards to: recruiting and selection, hiring and termination, training, professional development, mentoring, counseling, performance evaluations, and salary planning.
Other duties as assigned.
Certification/Skills:
Depending on clinical trial, an RN registered in the state of Texas might be required. Depending on clinical trial a Human subjects training certificate might be required. Bilingual–English/Spanish preferred.
Minimum Education:
Bachelor’s degree. In the event that an RN degree is required, the bachelor’s degree may be waived.
Minimum Experience:
Seven (7) years of relevant experience. 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. This position may include work involving potentially hazardous chemical, biological or radioactive agents.
Security Sensitive:
This job class may contain positions that are security sensitive and thereby subject to the provisions of Texas Education Code § 51.215.
Residency Requirement:
Employees must permanently reside and work in the State of Texas.
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