Office assistant Jobs in Westminster, CO

IND / IDE Office Assistant Director

Reporting to the Assistant Vice Chancellor for Clinical Research Operations in the Office of the Vice Chancellor for Research (OVCR), the IND / IDE Office Assistant Director is a high impact and high visibility role, responsible for developing, managing, and overseeing the activity for the IND / IDE office, including regulatory strategy. This position will work closely with other leaders in the OVCR, Cancer Center, Gates Institute, and CHCO to support CU held INDs and CU investigator-held INDs.

Key responsibilities include :

• Supervising staff on the IND / IDE team
• Managing an IND / IDE office that is responsible for oversight of all locally held IND / IDEs on campus including for products manufactured on campus
• Aiding in the onboarding process for IND / IDE staff
• Designing a cascading goal setting and performance infrastructure that ensures individual alignment to the strategic plan and fosters personal and professional growth
• Developing and implementing SOPs, training programs, and quality management systems for the IND / IDE office
• Overseeing preparation, submission, and maintenance of INDs and IDEs for early-phase and first-in-human studies performed on the CU Anschutz Campus Operations
• Collaborating with investigators, IRBs, research administration, and legal teams to navigate regulatory pathways for novel therapeutics and devices
• Convening and leading teams to develop and execute organization-wide initiatives, including the successful implementation of cellular therapy clinical trials through the IND / IDE office
• Providing oversight of appropriate financial controls and fiduciary stewardship to determine areas vulnerable from an audit perspective and develop plans, recommendations, policies, and procedures to strengthen those areas
• Evaluating, selecting, and managing external regulatory consultants supporting translational research initiatives by developing and providing strategic regulatory guidance for projects in which the Anschutz Medical Campus leads or participates, including complex multi-institutional research awards
• Oversight of external consultants developing regulatory strategy
• Working with University Communications to communicate study milestones and progress, ensuring transparency, accountability, and strategic context
• Ensuring timely communication and appropriate escalation of unresolved obstacles to trial opening
• Working closely with the OVCR and IND / IDE staff to ensure projects are appropriately resourced
• Ensuring the leadership team is continually apprised of the strategic landscapewithin the team and externalto anticipate and capitalize on existing and emerging strengths and opportunities and address weaknesses and potential threats
• Acting as a change agent and serving as a major point of contact for problem resolution

Strategic development includes :

Work location : Hybrid this role is eligible for a hybrid schedule of 2 days per week on campus and as needed for in-person meetings.

Why join us? The mission of this group is to partner with CU Anschutz investigators and stakeholders to develop innovative therapies and facilitate the regulatory and operational conduct of clinical trials. This role requires expertise in FDA regulations (21 CFR Parts 312, 812) and serves as a primary liaison among investigators, sponsors, regulatory agencies, and institutional stakeholders.

Why work for the University? We have AMAZING benefits and offer exceptional amounts of holiday, vacation, and sick leave! The University of Colorado offers an excellent benefits package including :

There are many additional perks & programs with the CU Advantage.

Minimum qualifications :

Preferred qualifications :

Knowledge, skills, and abilities :

How to apply :

Questions should be directed to : Benjamin Echalier, Benjamin.Echalier@cuanschutz.edu

Screening of applications begins immediately and continues until position is filled. For best consideration, apply by December