Clinical Science Program Manager, GN Trials

University of Colorado; Aurora (CO); Hybrid; USD 70,000 - 90,000; Full time

Benefits offered by this job

Vacation days 22/year

Sick days 15/year (unlimited accrual)

Holiday days 15/year

Tuition benefit for CU campuses

ECO Pass

Job summary

University of Colorado Anschutz Medical Campus is seeking a Clinical Science Program Manager for GN Trials to lead and manage all aspects of approximately 8 trials related to rare inflammatory kidney disease.

The role oversees two coordinators, develops policies, and maintains regulatory and financial oversight, with a hybrid schedule on campus four to five days per week and in-person meetings as needed.

Qualifications

• Bachelor’s degree required; combination with related experience may substitute for a degree.
• Four years of clinical research or related experience.
• Strong knowledge of federal regulations and Good Clinical Practice (GCP).

Responsibilities

• Independently manage administrative, personnel, financial, and contracting functions for GN trial group.
• Oversee management of two clinical trial coordinators, including evaluations and advising.
• Develop policies and procedures as required.
• Maintain financial oversight: salary, expenses, invoicing, budgets, contracts, and reconciliations.
• Maintain regulatory oversight in startup, maintenance, and close-out of studies.
• Interface with IRB, coordinators, investigators, sponsors, and monitors to ensure compliance.

Skills

Project management

GCP knowledge

Analytical skills

MS Office / Microsoft Suite

Strong written and verbalcommunication

Relationship building

Customer service

Medical terminology knowledge

Research protocol mastery

Education

Bachelor’s degree (any field)

Bachelor’s degree in science/health field

Tools

EMR/EHR systems

Job description

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

University of Colorado Anschutz Medical Campus

Department: School of Medicine, Department of Medicine, Division of Renal Diseases and Hypertension

Job Title: Clinical Science Program Manager, GN Trials

Position #: 00853550 - Requisition #: 41214

The Renal Division has a robust clinical trials program with its own dedicated space for administrative and clinical operations. This particular position offers the opportunity to lead and manage all aspects of approximately 8 trials (from interventional treatment to biobank) for rare inflammatory kidney disease (glomerulonephritis).

Key Responsibilities

• Independently manage the administrative, personnel, financial, and contracting functions for the GN trial group within the larger kidney disease renal research office.
• Oversee management of two clinical trial coordinators, including evaluations, troubleshooting, and advising, ensuring staff meet all requirements related to their assigned studies.
• Develop policies and procedures, as required.
• Maintain financial oversight of GN group research trials. Tasks include salary and expense allocations, invoicing, developing clinical trial budgets, negotiating contracts, and reconciling accounts.
• Maintain regulatory oversight in the startup, maintenance, and close-out of clinical research studies.
• Routinely interface with IRB, coordinators, investigators, sponsors, and monitors to ensure overall compliance with policies and procedures for conducting good clinical trials.

Work Location

Hybrid – this role is eligible for a hybrid schedule of four to five (4-5) days per week on campus and as needed for in-person meetings.

Why Join Us

Our dedicated research office faculty and staff make for a vibrant, supportive, and collaborative group to work with. Additionally, if you are someone who strives to grow and learn, you would be a proud part of the University of Colorado Anschutz Medical Campus, which is a world-class medical destination at the forefront of life-changing science, medicine, and healthcare.

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

Qualifications

Minimum Qualifications

• Bachelor’s degree in any field.
• Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year-for-year basis.
• Four (4) years of clinical research or related experience.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications

• Bachelor’s degree in science or health-related field.
• Five (5) years of clinical research or related experience.
• Prior experience providing program and/or project management duties in a clinical research setting.
• Experience with electronic data capture systems (e.g., EMR or EHR and data management systems).

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

• Strong project management skills and experience within a complex and diverse environment.
• Advanced knowledge and understanding of federal regulations and Good Clinical Practice (GCP).
• Demonstration of strong analytical and problem-solving skills.
• Demonstration of strong technological and Microsoft Suite skills.
• 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.
• Knowledge of basic human anatomy, physiology, and medical terminology.
• Ability to interpret and master complex research protocol information.

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 [e-mail].

Background Check Statement

The University of Colorado Anschutz Medical Campus 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.

Anticipated Pay Range

The starting salary range (or hiring range) for this position has been established as $70,446 to $89,607.

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.