Investigational Drug Service Pharmacy Fellow

Investigational Drug Service Pharmacy Fellow

Description

University of Colorado Anschutz Medical Campus – Department of Clinical Pharmacy

Job Title:

Investigational Drug Service Pharmacy Fellow

Position # - Requisition #36872

The Investigational Drug Service (IDS) Pharmacy Fellowship at the CU Research Pharmacy (CURP), located on the Anschutz Medical Campus, offers a one- or two-year post-Pharm

D 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 engage in operational and regulatory aspects of IDS through longitudinal experiences that include clinical trial support, IRB participation, independent research, and pharmacy student precepting.

The fellowship emphasizes professional development through mentorship, tailored learning plans, and opportunities for scholarly activity. Fellows will leave prepared to contribute to the evolving landscape of clinical research pharmacy.

Work location:

onsite in Aurora, CO.

• 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

• A Pharm
  
  D degree from an ACPE accredited school of pharmacy

• Experience with investigational drug services, clinical research operations, or IRB/regulatory processes
• Research experience

• 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 documentation of processes clearly and ability to communicate 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 GCP.
• 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 and address logistical challenges.
• Interest in academic scholarship and professional development, including mentoring pharmacy students and engaging in research suitable for publication or presentation.

Onsite

The University of Colorado Anschutz Medical Campus is an Equal Opportunity Employer and complies with all applicable…