This Clinical Trial Program Manager will oversee daily operations, personnel management, and staff training for our Alzheimer's/dementia and neuromuscular research programs. The ideal candidate is a collaborative individual who fosters a harmonious team environment, enabling strategic focus for the senior manager.
The ideal candidate has prior managerial experience, preferably in healthcare. Experience in neurology clinical research is a bonus as well but not required.
This position will be supporting a research team comprised of 15-20 research coordinators, nurses and providers under the ultimate direction of Dr. Paul Schulz. The team is highly collaborative and supports trials in both dementia and neuromuscular conditions. The group supports both sponsored and investigator initiated trials.
Position Summary:Coordinates and manages subject recruitment, site development, enrollment of human subjects and clinical trial monitoring.
Position Key Accountabilities:- Oversees all aspects of the clinical trial.
- 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.
- Interacts with project teams and provide required/necessary training.
- May create annual budget, negotiate with service contracts, and reports on progress and authorizes expenditures.
- 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
- 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.
- 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) depending on clinical trial, may be required
Minimum Education:Bachelor's Degree required In the event that an RN degree is required, the bachelor's degree may be waived
Minimum Experience:5 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 A751.215 and Texas Government Code A7411.094. 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 A7117.001(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. A7791.4.
Residency Requirement:Employees must permanently reside and work in the State of Texas.
