Department of Neurology and Rehabilitation Medicine
University of Cincinnati, College of Medicine
The University of Cincinnati is a premier, public, urban research university; ranked as one of America’s top 26 public research universities by the National Science Foundation. U.S. News has ranked UC in the Top Tier of America’s Best Colleges. The Chronicle of Higher Education calls UC a “research heavyweight”. Forbes, Delta Sky and Travel + Leisure magazines have named UC one of the most beautiful campuses. #HottestCollegeInAmerica
UC is one of the largest employers in the Cincinnati region, employing over 15,000 full time and part time faculty, staff and student workers. The College of Medicine, Department of Neurology and Rehabilitation Medicine is recruiting for a full-time (100% FTE) NIH StrokeNet National Coordinating Center (NCC) Research Pharmacist. The Research Pharmacist will be hired as Clinical Research Director who will be responsible for all aspects of investigational product management and distribution for clinical studies for Infectious Diseases and StrokeNet.
Job Duties and Responsibilities:
Maintains investigational drug and drug accountability adhering to all NIH, NIAID, NINDS and other applicable federal pharmacy guidelines.
Maintains copies of each protocol that is IRB approved including all subsequent amendments and versions while adhering to all institutional and federal guidelines.
Maintains copies of the first and last pages of signed current informed consents that have been approved by the IRB for each protocol.
Maintains all current FDA form 1572s and Investigator of Record (IoR) forms and signature pages.
Ensures that outpatient dispensing is done according to guidelines in the most current IRB approved version of all protocols.
Liaises with protocol principal investigators to establish pharmacy’s role in the trial for study drug compounding, packaging, and dispensing.
Liaises with external agencies/organizations, as required.
Monitors pharmacy activities to ensure adherence to study protocols and dispensing procedures.
Communicates with, and trains staff anticipated to participate in any aspect of the clinical investigational drug trial.
Maintains a pharmacy binder (paper or electronic) which contains a study summary, protocol, dispensing procedures, dispensing checklist, and any other relevant materials for each investigational trial.
Available by prior scheduling request to dispense medications if needed for after-hours.
Maintains investigational drug inventory.
Performs an ongoing perpetual inventory and a monthly total inventory of all investigational products.
Responsible for correct ordering, storage, dispensing and return of investigational agents according to IRB, state and federal (NIH, FDA) requirements.
Maintains investigational research database for assisting with drug accountability, dispensing and return of investigational products.
Attends bi-weekly staff meetings.
Participates in all new study start-up meetings.
Serves as an educational resource to study participants and other staff regarding drug dispensing, dosing allowed concomitant medications, and drug interactions with non-study medications, other dosing requirements (food effects, etc).
For each research study, correctly stores, dispenses, and records investigational product according to sponsor’s instructions, participant’s randomization; maintains study blinding where appropriate.
Orders new study-specific inventory in a timely fashion so that study drug administration is uninterrupted.
Returns unused study drug to sponsor according to study-specific requirements.
Cooperates with study monitors during site visits to facilitate oversight on study drug storage, dispensing and accountability.
Constructs and maintains Pharmacy Plan and all standard operating procedures as needed for the investigational pharmacy.
Completes all required research training and maintains certificates of Good Clinical Practice and Human Subjects Protection as required by institution, State and Federal Agencies (e.g., NIH, FDA, OHRP).
Maintains Ohio Pharmacist license in accordance with Ohio State Board of Pharmacy.
Maintains Ohio Pharmacy License for the Clinical Trials Research Pharmacy in accordance with the Ohio State Board of Pharmacy, including required text books.
Supervises research pharmacy technician as required. Delegates work assignments and checks work orders filled by technicians.
Fulfills all requirements to serve as StrokeNet National Coordinating Center Central Pharmacist.
Coordinates time off with back up pharmacist.
Attends annual ACTG, HPTN, StrokeNet and other Network meetings as required.
Other related duties, as assigned.
Ohio License from State Board of Pharmacy
RPh or PharmD
Previous experience with investigational drug management preferred but not required
Meticulous documentation skills
Excellent oral and written communication skills
Ability to Obtain Independent Pharmacy Licensure from State Board of Pharmacy
Eligibility to apply for an institutional DEA license
Eligibility to apply for a wholesale license
The University of Cincinnati, as a multi-national and culturally diverse university, is committed to providing an inclusive, equitable and diverse place of learning and employment. As part of a complete job application you will be asked to include a Contribution to Diversity and Inclusion statement.
The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / M / F / Veteran / Disabled.
HISTORY IN BRIEF - The University of Cincinnati is a public urban serving research institution that was founded in 1819 and today is one of the country’s largest universities offering more than 350 academic programs to more than 44,000 students. UC has many top ranked programs in areas such as Music and Arts, Medical and Human-Services, Criminal Justice and more. Located in an urban setting, UC is... close to the heart of Cincinnati and allows easy access for students to enjoy all that the city offers. UC is also the alma mater of many notables such as President William Howard Taft; Albert Sabin, developer of the oral polio vaccine; Astronaut Neil Armstrong and Mary Weinberg, 2008 Olympic gold medalist. UC is classified as a Research University (Very High Research Activity) by the Carnegie Commission and is ranked as one of America’s top 35 public research universities by the National Science Foundation. UC jumped 17 spots in the U.S. News & World Report rankings in the past two years alone. In addition to being named a “green university” by Princeton Review, UC has been named one of the world’s most beautiful campuses by Forbes and Delta Sky magazines. Learn more at www.uc.edu.MISSION STATEMENT - The University of Cincinnati serves the people of Ohio, the nation, and the world as a premier, public, urban research university dedicated to undergraduate, graduate, and professional education, experience-based learning, and research. We are committed to excellence and diversity in our students, faculty, staff, and all of our activities. We provide an inclusive environment where innovation and freedom of intellectual inquiry flourish. Through scholarship, service, partnerships, and leadership, we create opportunity, develop educated and engaged citizens, enhance the economy and enrich our University, city, state and global community.