The Program Manager - Research supports the clinical, research, and administrative operations of the Huntington's Disease Society of America Center of Excellence. This position works closely with the Center Director to coordinate multidisciplinary clinical services, oversee clinical research activities, facilitate industry-sponsored and investigator-initiated studies, and manage Center initiatives. The role serves as a liaison among investigators, sponsors, institutional offices, clinical staff, patients, and external collaborators to ensure the successful execution of clinical and research programs.
Position Summary:Develops, plans, maintains research and policy analysis. Oversees the general running of the laboratory.
Position Key Accountabilities:- Manages the research agenda for the area.
- Sets deadlines, assigns responsibilities, monitors the progress of projects, and provides supervision and guidance to the research personnel, research nurses and administrative staff.
- Facilitates collaboration between clinicians and research scientist, internal and external to the University.
- Assists with the annual budget, negotiates service contracts, reports on progress and authorizes expenditures.
- Informs upper management of key activities.
- Assists in grant proposals to both private foundations and governmental agencies.
- May work closely with the Office of Sponsored Projects on the submission of grants.
- May conduct or supervise training related to research for internal, hospital, and community groups.
- Manages on-going strategic plans for the area.
- Communicates with community and professionals to share objectives and outcomes.
- Prepares/makes oral presentations at professional meetings.
- May also participate in committees as deemed appropriate for the department.
- Stays abreast of new and updated protocols for the department.
- 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.
Additional Responsibilities:- Coordinate day-to-day operations of multidisciplinary HD clinic.
- Manage study start-up activities, including feasibility assessments, regulatory submissions, budget development and negotiation, contract coordination, coverage analysis, site activation, and study implementation.
- Coordinate industry-sponsored, federally funded, and investigator-initiated clinical research studies from start-up through close-out.
- Develop study timelines, monitor project milestones, and oversee participant recruitment, enrollment, retention, and study progress.
- Collaborate with sponsors, CROs, and institutional offices to facilitate study activation and regulatory compliance.
- Work with the department and SPA Pre-award teams to prepare and negotiate clinical trial budgets and monitor study financial performance.
- Ensure compliance with FDA regulations, GCP, HIPAA, institutional policies, and sponsor requirements.
- Coordinate sponsor monitoring visits, audits, and regulatory inspections.
- Develop and implement operational workflows and quality improvement initiatives to enhance clinical and research efficiency.
- Prepare reports, maintain study and Center databases, and assist with grant submissions, annual reports, and other administrative activities.
- Assist with supervision, training, and coordination of research personnel and students.
- Support patient education, community outreach, and HDSA Center of Excellence activities.
Certification/Skills:- Depending on research may require advanced level grant writing skills.
- 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) may be required
- Certified Clinical Research Coordinator (CCRC) by Association of Clinical Research Professionals (ACRP) may be required
- Certifications specific to the program required
Minimum Education:Bachelor's Degree in Science or a health administration related field required
Minimum Experience:5 years of applicable experience required May substitute required experience with equivalent years of education beyond the minimum education requirement.
Preferred Qualifications:- Experience managing clinical trial start-up activities, regulatory submissions, and budget development/negotiation.
- Knowledge of FDA regulations, GCP, and clinical research operations.
- Excellent organizational, communication, and project management skills.
- Master's degree in a related field.
- Experience in neurology, neurodegenerative diseases, or movement disorders.
- Experience coordinating industry-sponsored clinical trials within an academic medical center.
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.
