CReST Operations Manager

Job Summary\:

The Clinical Research Support Team (CReST) is part of the Office Clinical Trials and provides institutional support to clinical investigators studying a multitude of indications in over 30 departments across the Anschutz Medical Campus. CReST supports clinical investigators for all activities related to the successful conduct of clinical research, from study start-up through close out. This is the cornerstone to translate basic science knowledge into clinically useful treatment for patients.

This role will oversee CReST staff working on studies in multiple indications, such as Radiology, Oncology, Endocrinology and multiple others, and ensure that these studies are conducted according to regulatory requirements, Good Clinical Practice, and applicable University and Sponsor policies. The CReST Operations Manager is responsible for managing a team of research coordinators and other staff (e.g., regulatory staff, junior managers) responsible for study coordination, regulatory tasks and data collection/entry; and is responsible for logistical support for office management and operations, study startup (including budget negotiation), performance review, hiring, and staff assignments. The Operations Manager will have independent decision making and leadership responsibilities, including operational strategic planning.

Key Responsibilities\:

Supervision Operations and Study Coordination (35%)

• Communicates with and relays timely information to sponsor, investigators, study staff, and CReST Team Members

• Responsible for development of onboarding and training of all project managers and providing high-level oversight of training programs for all coordinator staff.

• Provides oversight of processes, studies, and employees

• Direct supervisory duties of project managers and/or senior staff, including directing the day-to-day work, coaching and mentoring, annual performance reviews and other management activities as needed.

Clinical Research Trials (10%)

• Provides general oversight of the coordination and regulatory/administrative services related to specific studies contracted with CReST

• Oversees study start-up and regulatory processes as a backup to the CReST managers and coordinators

• Provides backup to project managers and coordinators related to study-specific tasks, as needed.

• Liaises with study teams and sponsors as needed to facilitate efficient and compliant study operations.

• Provides backup to project managers and coordinators for regulatory submissions to local and central IRBs, FDA, and other regulatory agencies.

• Budgeting and Finance

• Acts as primary contact for study sponsor representatives and study subjects for research studies

• Provides backup support for study budget development and negotiation.

• Performs or directs invoicing and invoice payment reconciliation.

• Performs or directs processes related to study subject payments.

• Monitors coordinator billable time and answers coordinator questions related to time tracking.

Regulatory Compliance (10%)

• Develops operational policies and procedures to standardize the responsibilities and communication to ensure operational compliance with Food and Drug Administration, National Institutes of Health and other federal, state, and institutional guidelines.

• Assures adherence to all research standards by CReST coordinators as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), and other pertinent regulatory agencies.

• Collaborates with key stakeholders to ensure harmonious policy development and operations related to trial conduct and compliance across various teams (e.g., CCTO, OCRST, CU Innovations, CRAO)

Budgeting and Finance (20%)

• Works in conjunction with CReST and OCT leadership on the development and reporting of CReST financial data and annual cost study.

• Completes or assists in the completion of monthly billing for CReST services and in maintaining functionality and training related to billing/time tracking tools.

• Oversees or takes direct responsibility for budget development, negotiation, invoicing, invoice payment reconciliation and other clinical trial finance tasks

Strategic Planning and Business Operations (10%)

• Assists CReST Leadership in the development and tracking of Key Performance Indicators and other essential metrics (e.g., startup time, billable hours, task types, customer characteristics)

• Initiates and directs special projects as needed related to CReST services, procedures, continuous improvement, and the needs of the CU research community.

• Assists CReST Leadership in career and organizational pathway development and planning.

• Cultivates relationships and connections with key stakeholders across the CU research community.

Human Resources (10%)

• Directly supervises CReST staff, including managers and/or other senior coordinator or regulatory staff as needed.

• Provides coaching, mentoring to all staff and mediation and corrective interventions as needed

• Facilities the hiring process for new project managers or other senior staff, including pre-screening interviews, scheduling group interviews, and reference checks. Serves as the Search Committee Chair, as needed.

• Serves as hiring manager for positions, as needed.

• Anticipates staffing needs and communicates with CReST Leadership and central HR to post and hire for positions.

• Oversees all HR processes for all direct reports including approving monthly timesheets, approving any sick time and vacation requests, and conducting annual performance reviews.

Other Duties - (5%)

• Oversees and manages office operations, including submitting work orders, ordering office supplies, and providing CReST leadership with key information related to office operations.

• Independent decision making and strategic thinking

• Other duties as assigned by Assistant Director

This description is a summary only and describes the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Work Location\:

Hybrid – this role is eligible for a hybrid schedule of 4 days per week on campus and as needed for in-person meetings.

Why Join Us\:

The Clinical Research Support Team (CReST) is part of Office of Clinical Trials. CReST provides a la carte support services to clinical investigators for all activities related to the successful conduct of clinical research, from study start-up through close out. This is the cornerstone to translate basic science knowledge into clinically useful treatment for patients.

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\:

• Medical\: Multiple plan options

• Dental\: Multiple plan options

• Additional Insurance\: Disability, Life, Vision

• Retirement 401(a) Plan\: Employer contributes 10% of your gross pay

• Paid Time Off\: Accruals over the year

• Vacation Days\: 22/year (maximum accrual 352 hours)

• Sick Days\: 15/year (unlimited maximum accrual)

• Holiday Days\: 15/year

• Tuition Benefit\: Employees have access to this benefit on all CU campuses

• ECO Pass\: Reduced rate RTD Bus and light rail service

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

Qualifications\:

Minimum Qualifications\:

• A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.

  • Substitution\: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis.

• 5 years clinical research experience

• 2 years supervisory experience

• Experience with Industry and Investigator-initiated clinical trials

• ACRP or SOCRA certification, must be obtained within 6 months of hire

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications\:

• Experience submitting to local and central IRBs

• Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification

• Experience with research budget and grant development for sponsored projects

• Experience with Industry and Investigator-initiated clinical trials

• Experience with NIH-sponsored and industry clinical research studies, including multi-center clinical trials

Conditions of Employment\:

• Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future.

Knowledge, Skills and Abilities\:

• Ability to communicate effectively, both in writing and orally.

• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.

• Outstanding customer service skills.

• Ability to interpret and master complex research protocol information

• Working knowledge of clinical trial regulations and Good Clinical Practice

• Technical/Procedural writing

• Superior organizational and time management skills

• Familiarity with RedCap and EPIC

• Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint)

• Knowledge of study start-up

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 (only use if a cover letter is necessary)

2. Curriculum vitae / Resume

3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to\: CARISSA FIGAL,CARISSA.FIGAL@cuanschutz.edu

Screening of Applications Begins\:

Immediately and continues until position is filled. For best consideration, apply by September 22, 2026.

Anticipated Pay Range\:

The starting salary range (or hiring range) for this position has been established as

$77,736 - $104,166

The above salary range (or hiring range) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator

Equal Employment Opportunity Statement\:

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.

ADA Statement\:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu​.

Background Check Statement\:

The University of Colorado Anschutz is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement\:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.