Investigational Drug Service Pharmacy Fellow

Job Summary The Investigational Drug Service (IDS) Pharmacy Fellowship at the CU Research Pharmacy (CURP), located on the Anschutz Medical Campus, offers a unique one- or two-year post-PharmD training experience focused on clinical research pharmacy operations, investigational drug management, and regulatory compliance. Fellows gain hands‑on experience with investigational product handling, protocol development, quality assurance, and interdisciplinary collaboration within an academic health system. This program is ideal for pharmacists interested in careers within academic medical centers, investigational drug services, or clinical research administration. Key Responsibilities Support the management of investigational products including receipt, storage, preparation, dispensing, accountability, disposal and documentation per study protocols and regulatory requirements. Assist in the development of pharmacy operations plans, blinding procedures, and emergency unblinding procedures for clinical trials. Participate in protocol review committees, site initiation visits, and feasibility assessments from the pharmacy perspective. Collaborate with study sponsors, principal investigators, research coordinators, and clinical teams to ensure safe and efficient investigational drug management. Ensure compliance with FDA regulations, IND requirements, Good Clinical Practice standards, USP standards and institutional policies. Contribute to regulatory submissions, including IRB applications and protocol amendments related to pharmacy operations. Conduct a research or quality improvement project in an area related to investigational drug services or clinical research pharmacy. Present findings at internal research days, professional meetings and prepare a manuscript for publication. Engage in educational activities such as journal clubs, seminars, and optional teaching activities. Work Location Onsite – the role is expected to work onsite and is located in Aurora, CO. Qualifications Minimum Qualifications: A PharmD degree from an ACPE accredited school of pharmacy. Eligibility for pharmacist licensure in the State of Colorado. If not already licensed in Colorado at the time of hire, candidates must obtain licensure within 90 days of their start date as a condition of continued employment. Preferred Qualifications: Experience with investigational drug services, clinical research operations, or IRB/regulatory processes. Research experience. Knowledge, Skills, and Abilities Strong foundational knowledge of pharmacy practice with a particular interest in clinical research, investigational drug management, and regulatory compliance in academic or health‑care settings. Excellent written and verbal communication skills , including the ability to document processes clearly, contribute to scholarly work, and communicate effectively with investigators, sponsors, and interdisciplinary team members. Demonstrated ability to work both independently and collaboratively , showing initiative, accountability, and adaptability within a fast‑paced research environment. Attention to detail and commitment to data integrity , particularly in maintaining investigational drug accountability records, reviewing protocols, and ensuring compliance with Good Clinical Practice (GCP) guidelines. Capacity to manage multiple projects or studies simultaneously , prioritizing tasks effectively while meeting deadlines and regulatory requirements. Critical thinking and problem‑solving skills to assess protocol feasibility, address logistical challenges, and contribute to quality assurance and process improvement initiatives. Interest in academic scholarship and professional development , including mentoring pharmacy students, participating in educational activities, and engaging in research suitable for publication or presentation. Equal Opportunity Statement The University of Colorado (CU) is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities. #J-18808-Ljbffr