"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.

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

Work Location

Onsite - this role is expected to work onsite and is located in Aurora, CO.

Why Join Us

The Skaggs School of Pharmacy and Pharmaceutical Sciences, located at the Anschutz Medical Campus, is an internationally renowned School of Pharmacy and a top tier research school ranked in the top 15 of more than 140 schools in the country for NIH research grant funding. At the Skaggs School of Pharmacy and Pharmaceutical Sciences, we are committed to excellence and innovation in professional, graduate and post-graduate education; scholarship and research; patient-centered care; public health advocacy; and societal leadership and engagement. Together, our innovation, discoveries and engagement with our communities improves the health and well-being of society.

Qualifications

Minimum Qualifications

• A PharmD degree from an ACPE accredited school of pharmacy

Condition of Employment: Candidates must be eligible 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 healthcare 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.

How to Apply

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position
2. Curriculum vitae / Resume
3. Five professional references including name, address, phone number (mobile number if appropriate), and email address

Applications are accepted electronically ONLY at www.cu.edu/cu-careers.

Questions should be directed to: Sam Ellis, Sam.Ellis@cuanschutz.edu

Anticipated Pay Range

The starting salary range (or hiring range) for this position has been established as HIRING RANGE: $67,555.68