Clinical Research Pharmacy Specialist (Center for Brain Health)

Job Description

The Clinical Research Pharmacist Specialist specializing in investigational drug services (IDS) is multifaceted, combining expertise in clinical pharmacy with the unique demands of managing investigational products in clinical trials. Will serve as a critical link between various stakeholders in the clinical research trial's operations and process. Coordinate and execute all aspects of investigational drug handling. Maintain accurate inventory records and drug accountability documentation. Oversee the use of investigational drugs according to IRB-approved protocols and contribute to safety monitoring efforts, including adverse event reporting. Assist in streamlining the complex process of drug development, from initial trials to potential market approval. Ensure adherence to federal and state regulations governing investigational new drugs (INDs) and compliance with Good Clinical Practice (GCP) guidelines and FDA regulations, in a hospital and clinical setting.

Responsibilities

• Serves as a key liaison between clinical trial operation teams, healthcare providers, protocol sponsors, pharmacy operations, and the EPIC team, ensuring seamless communication and coordination.
• Leads and actively participates in investigational drug service initiatives, including education, clinical research, performance improvement, drug accountability, study audits, and professional development.
• Assess individual protocols for coherence, soundness, feasibility, and practicality, contributing to research protocol reviews and evaluations.
• Develop comprehensive procedural materials, order sets, and resources for investigational product preparation and dispensation within the pharmacy.
• Provides timely medication information and education to staff and patients regarding investigational drug services, including potential side effects and drug interactions.
• Participates in clinical trial office committees and initiatives to develop, improve, and implement new strategies and tools for enhancing investigational workflow.
• Oversees the preparation, packaging, and distribution of investigational treatments, ensuring compliance with protocol requirements and safety standards.
• Maintains accurate and detailed records on patient prescriptions, charges, inventory, and drug returns, adhering to regulatory requirements and institutional policies.
• Supervises and guides pharmacy technicians.
• Analyzes, compares, and evaluates various courses of action, making independent decisions to optimize clinical trial processes and outcomes.
• Conduct regular audits and quality checks to ensure compliance with Good Clinical Practice (GCP) guidelines, FDA regulations, and institutional policies.
• Collaborates with research teams to design and implement pharmacokinetic and pharmacodynamic studies within clinical trials.
• Performs all other duties as assigned, maintaining flexibility to adapt to the evolving needs of the hospital and clinical research environment.
• Helping design and conduct clinical trials through the Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases and Department of Neurology.

Qualifications

• Comprehensive understanding of medicine, pharmacology, and current standard of care treatments.
• In-depth knowledge of Good Clinical Practice (GCP), investigational drug use/handling protocols, and FDA approval processes for new drugs.
• Proficiency in aseptic technique and non-sterile compounding, strongly emphasizing preventing contamination.
• Advanced knowledge of inventory management procedures and expertise in utilizing pharmacy information systems and electronic health records.
• Excellent attention to detail and maintaining accuracy while implementing effective quality control measures.
• Strong verbal, written, and interpersonal communication skills and ability to interact with diverse stakeholders in the clinical research process.
• Adaptability and resilience in managing uncertainty and rapid change, with strong problem-solving and decision-making skills.
• Provide reliable, responsive, safe, and courteous service to stakeholders while promoting an inclusive and collegial work environment.
• Understanding FDA health regulations and legal compliance requirements and providing accurate and timely medication education and counseling to patients and healthcare professionals.
• Expert knowledge of dosage administration, measurement techniques, chemical compounds, and pharmaceutical brands, including investigational and approved medications.
• Proficiency in data analysis and interpretation, with the ability to contribute to clinical trial design and protocol development.
• Strong project management skills, including the ability to coordinate multiple clinical trials while maintaining quality standards.

About Us

Benefits Overview

UT Health San Antonio offers an excellent benefits package for its employees. Employees who work at least 20 hours a week, with an appointment of at least 4.5 months, are eligible for benefits.

Medical - UT SELECT Medical insurance is offered free for employees and administered by Blue Cross and Blue Shield of Texas. Family members can be added to the plan through payroll deduction. Employees and their dependents can also receive discounted copays and coinsurance when using UT Health Physicians, a network of 800 premier physicians including more than 100 specialists. Employees receive $50,000 of group term life insurance and $50,000 of basic accidental death and dismemberment insurance for free, with options to purchase additional employee and dependent coverage for both at group rates.

Dental - Three dental insurance plan options are available for employees and their families through Delta Dental Insurance Company, two PPOs and one dental HMO plan. Both PPO plans allow employees to choose any licensed dentist.

Vision - Fully insured Vision Care benefits are offered by Superior Vision Services. Two vision plan options that offer either standard or enhanced vision benefits.

Disability - Employees can enroll in the Disability Insurance which provides income if a non-work related illness or injury prevents you from working.

FSAs - Employees can enroll in flexible spending accounts (FSAs) to set aside money from earnings before taxes for qualifying dependent day care expenses or out-of-pocket health care expenses.

Retirement - Employees are eligible for either the Teacher Retirement System (TRS) or the Optional Retirement Plan (ORP). TRS is a defined benefit retirement plan which UT Health matches employee contributions. ORP is for eligible faculty staff employees. Voluntary retirement programs are also available to invest before- or after-tax dollars with the choice of five quality retirement plan providers.

Time Off - A generous leave program offers multiple paid leave options:

• Front-loaded Paid Time Off: 128 to 208 hours (16 to 26 days) of Paid Time Off based on years of service, given at the start of each fiscal year. PTO may be prorated in year one based on date of hire.
• Extended Illness Bank: 8 hours (1 day) accrued per month which can be used for illness or injury after one day of Paid Time Off is taken.
• Paid Family Leave: Up to 240 hours (6 weeks) to care for a spouse, child, or parent after 6 months of consecutive employment.
• Holidays: 12 set paid holidays each year.

Discounts - Employees enjoy a range of discounts on services, tickets, and gym membership.

EEO Statement

UT Health San Antonio is an equal employment opportunity and affirmative action employer. It is our policy to promote and ensure equal employment opportunity for all individuals without regard to race, color, religion, sex, gender identity, national origin, age, sexual orientation, disability, or veteran status.