Summary
The Investigational Drug Pharmacist plays a crucial role in the management and
oversight of investigational drugs used in clinical research trials. This
position ensures the safe and effective use of investigational medications,
compliance with regulatory requirements, and support for research activities.
The Investigational Drug Pharmacist collaborates with research teams, monitors
drug handling and storage, and provides expert advice on pharmaceutical care
related to investigational drugs. The Investigational Drug Pharmacist will work
closely with principal investigators (PI), clinical research coordinators and
local site research pharmacists and will be responsible for the review,
evaluation, and coordination of investigational drug research studies for the
system at Baptist Health.
Job Description:
Baptist Health is looking for a System, Investigational Drug Pharmacist (Hybrid)
to join our Pharmacy team at 4003 Kresge Way, Louisville, KY!
This is a hybrid role consisting of 3 - 4 days per week on-site. Additionally,
this position requires occasional travel (averaging 2 - 4 days per month) to
various Baptist Health locations throughout Kentucky and southern Indiana.
* Design, implement, and manage research projects related to medication systems
and clinical pharmacy practices.
* Evaluate, interpret and coordinate information relating to drug research
studies for the System.
* Assist local sites with enrollment, randomization, blinding, logging,
preparation, dispensing, delivery, accounting and storage of investigational
drugs.
* Prepare and review documentation for Investigational New Drug (IND)
applications and other regulatory submissions.
* Serve as a system expertise on research studies and clinical trials that the
BH system is enrolled in.
* Assist in the development of Standard Operating Procedures and Policies
relating to investigational/research drugs.
* Ensure compliance with FDA regulations, Good Clinical Practice (GCP), and
institutional policies.
* Conduct audits, site visits and inspections to ensure adherence to regulatory
requirements and ensure accurate documentation and records of research
activities and outcomes are maintained.
* Participate in quality improvement initiatives and projects aimed at
enhancing medication safety and patient care for investigational drugs.
* Ensure the ethical use of investigational drugs and the protection of patient
safety.
* Prepare and submit reports on drug-related issues to regulatory agencies and
internal stakeholders.
* Maintain and analyze data related to investigational drug use and outcomes.
* Assist with responding to any queries or audits by federal and state agencies
with regards to clinical trials or investigational drugs.
* Work closely with clinical, regulatory, and quality assurance teams to ensure
the smooth conduct of clinical trials.
* Collaborate with system and local clinical research teams to support trial
design and drug protocol development.
* Provide education and training to pharmacy staff and other healthcare
professionals on new systems, practices, and research findings.
Minimum Requirements
* Bachelor's degree in pharmacy, or higher.
* KY Board of Pharmacy License.
* 3 years of job-related experience required.
* Valid driver's license.
* Requires occasional travel to various Baptist Health locations across
Kentucky and southern Indiana, averaging 2 - 4 days per month.
IF YOU WOULD LIKE TO BE PART OF A GROWING FAMILY FOCUSED ON SUPPORTING CLINICAL
EXCELLENCE, TEAMWORK AND INNOVATION, WE URGE YOU TO APPLY NOW!
BAPTIST HEALTH IS AN EQUAL EMPLOYMENT OPPORTUNITY EMPLOYER.