System Investigational Drug Pharmacist - Hybrid...

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., Baptist Health is looking for a System, Investigational Drug Pharmacist (Hybrid) to join our Pharmacy team at 4003 Kresge Way, Louisville, KY!

This is ahybrid roleconsisting of 3 - 4 days per week on-site. Additionally, this position requiresoccasional 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 clinicalpharmacy 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 otherregulatory 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 andensure accurate documentation and records of research activities and outcomes are maintained.

Participate in quality improvement initiatives and projects aimed at enhancing medication safety andpatient 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 clinicaltrials or investigational drugs.

Work closely with clinical, regulatory, and quality assurance teams to ensure the smooth conduct ofclinical trials.

Collaborate with system and local clinical research teams to support trial design and drug protocoldevelopment.

Provide education and training to pharmacy staff and other healthcare professionals on newsystems, practices, and research findings.

Bachelor’s degree in pharmacy, or higher.

KY Board of Pharmacy License.

3 years of job-related experience required.

Valid driver’s license.