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.
Fellows will engage in both operational and regulatory aspects of investigational drug services through longitudinal experiences that include clinical trial support, IRB participation, independent research, and pharmacy student precepting. The fellowship emphasizes professional development through one-on-one mentorship, tailored learning plans, and opportunities for scholarly activity. Fellows will leave the program prepared to contribute meaningfully to the evolving landscape of clinical research pharmacy.
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
