Advanced Practice Pharmacist

Develop study-specific procedures for investigational drug preparation, dispensing, accountability, handling, storage, documentation, and record retention.

Coordinate pharmacy participation in study initiation, implementation, protocol amendments, monitoring visits, audits, and study close-out.

Ensure compliance with FDA regulations, Good Clinical Practice (GCP), DEA requirements, Maryland Board of Pharmacy regulations, sponsor requirements, and institutional policies.

Develop, implement, and maintain IDS policies, standard operating procedures, quality assurance activities, and regulatory documentation.

Oversee sterile and nonsterile compounding of investigational products in accordance with USP standards.

Manage investigational drug inventory, accountability, returns, destruction, temperature monitoring, and documentation.

Assist in obtaining and maintaining Maryland pharmacy licensure for the IDS.

Collaborate with investigators, research coordinators, nursing, and pharmacy staff to support safe and efficient conduct of clinical trials.

Supervise IDS personnel and provide education to pharmacists, pharmacy learners, investigators, and research staff regarding investigational drug procedures and regulatory requirements.

Promote continuous quality improvement while expanding IDS capabilities to support the growth of the University's industry-sponsored clinical research portfolio.

Qualifications :

Education: Bachelor's degree in pharmacy. Doctoral degree in pharmacy (Pharm.D) preferred.
Experience: Two (2) years of experience in a pharmacy, OR

One (1) year post-baccalaureate or post-doctoral/post-graduate pharmacy residency (PGY1) plus one (1) year of experience, OR

Two (2) years post-baccalaureate or post-doctoral/post-graduate pharmacy residency (PGY2).
Certification/Licensure: Current Maryland licensure in good standing to practice as a pharmacist or a federal district licensure where the work will be performed upon hire.

Certification in a relevant specialty by the Board of Pharmacy Specialties or Commission for Certification in Geriatric Pharmacy Board such as Certified Psychiatric Pharmacist (BCPP) or Board Certified Geriatric Pharmacist (BCGP) eligibility preferred.
Other: Candidates selected for employment may be subject to medical inquiries and/or medical examinations to determine ability to perform the job. Employees in this job class may be subject to pre-employment and random drug testing.· Current pharmacist license in good standing (Maryland licensure or eligibility required).

Knowledge, Skills, and Abilities
Experience with sterile and nonsterile compounding. Demonstrated knowledge of FDA regulations, Good Clinical Practice (GCP), investigational drug accountability, USP compounding standards, and clinical research operations. Excellent leadership, organizational, communication, and project management skills. Experience in investigational drug services, clinical research pharmacy, or related practice preferred.

Hiring Range: $135,000 - $150,000, commensurate with education and experience.

UMB is committed to cultivating a diverse and inclusive workforce and is proud to be an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, ancestry or national origin, sex, pregnancy or related conditions, sexual orientation, gender identity or expression, genetic information, physical or mental disability, marital status, protected veteran's status, or any other legally protected classification.

If you anticipate needing a reasonable accommodation for a disability under the Americans With Disabilities Act (ADA), during any part of the employment process, please submit a UMB Job Applicant Accommodation Request . You may also contact leave_and_accom@umaryland.edu . Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address.

The University of Maryland, Baltimore prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator. Read the UMB Notice of Non-Discrimination for more information.