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.