Clinical Trials Operations Specialist

CU Denver; Aurora (CO); Hybrid; USD 59,000 - 79,000; Full time

Benefits offered by this job

Tuition Benefit

Retirement 401(a) Plan: 10% employer

Paid Time Off

Vacation 22/year

Sick Days 15/year

Holiday Days 15/year

ECO Pass

Job summary

The University of Colorado Anschutz, Gates Institute, is seeking a Clinical Trials Operations Specialist to connect science and operations for Phase I studies, including regenerative, gene, and cellular therapy trials.

In this hybrid role, you will lead day-to-day trial operations from startup to close-out, develop study plans, track milestones and budgets, and coordinate with sponsors, investigators, and regulatory bodies to ensure compliant, timely activation and completion.

Qualifications

• Bachelor's degree in a related field from an accredited institution.
• 2+ years of professional level experience in clinical trial operations.

Responsibilities

• Independently coordinates day-to-day operations and compliance of multiple Phase 1 trials from start-up to close-out.
• Develops a project plan for study protocols to meet timelines, milestones, and budgets.
• Supports core team meetings ensuring goals, deliverables, risks, and actions are tracked.
• Acts as liaison between site and internal/external stakeholders to ensure timely study activation and maintenance.
• Collaborates with leadership to resolve barriers to trial activation and improve timelines.
• Assists in developing protocol-specific systems and documents (SOPs, CRFs).
• Consults with investigators on submissions and responses to regulatory bodies.

Skills

Strong critical thinking

Excellent communication

Multi-tasking

Organizational skills

GCP/FDA knowledge

Microsoft Office (Excel/PowerPoint/PM)

Education

Bachelor's degree

Tools

Microsoft Excel

Microsoft PowerPoint

Microsoft Word

MS Project

Job description

University of Colorado Anschutz

Department: Gates Institute

Job Title: Clinical Trials Operations Specialist

Position #: 00822863 - Requisition #: 40937

Job Summary

The Clinical Trial Operations Specialist is responsible for connecting science and operations to bring clinical studies to life through the execution of Phase I clinical trials. This position will be primarily responsible for executing efforts to operationalize regenerative, gene, and cellular therapy clinical trials while building and maintaining strong and impactful relationships and working cross-functionally and collaboratively support trial operations.

Key Responsibilities:

• Independently coordinates the day-to-day operations and compliance of multiple highly complex Phase 1 clinical trials, across internal and external teams, from start-up to close-out.
• Develops a project plan for the study protocols to ensure the projected timelines, milestones, and budgets are met; provides senior leadership with metrics and updates as required.
• Supports core team meetings for assigned studies ensuring goals and deliverables are clearly dened, and issues, decisions, risks, and actions are appropriately tracked.
• Acts as the primary resource and liaison between the site and internal/external stakeholders, to ensure timely study launch, administrative study maintenance, and closeout in accordance with local, state, and federal regulations, as well as contractual obligations.
• Works closely with leadership, internal constituents, ancillary committees, and external Sponsors to resolve barriers to trial activation and improve protocol activation timelines.
• Assists in the development of protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs), and Case Report Forms (CRFs).
• Consults with investigators in developing submissions and responding to questions and requests for revisions from internal and external committees and boards (e.g., IRB).

Work Location

Hybrid - this role is eligible for a hybrid schedule of 3 day per week on campus and as needed for in-person meetings.

Why Join Us

The opportunity offered by the Gates Institute is one of a kind.

They blend the best of a large research organization of over 40,000 employees strong, with the family atmosphere of working with a team of 50+ highly dedicated people, operating on a top tier research campus - the University of Colorado - Anschutz Medical Campus.

The Gates Institute and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more every day. They are only limited by their resources and need you to make their journey a success!

We have AMAZING benefits and offerexceptional 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 business, business administration, nursing, finance, accounting, education, social sciences, physical/biological sciences, engineering, healthcare administration, public administration, communications, information systems, or a directly related field from an accredited institution.
  • 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.
• At least 2 years of professional level experience in clinical trial operations.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications

• Master's degree in health-related discipline.
• Registered Nurse (RN) licensure or prior professional clinical experience.
• Experience with coordinating operations of clinical trials in the cellular and/or gene therapy space.
• Certified as a Clinical Research Professional (CCRP or equivalent).
• Experience submitting Investigational New Drug (IND) applications.
• Certified Associate in Project Management (CAPM), Project Management Professional (PMP) Certification, and/or project management experience in an academic environment.
• Professional clinical research experience in an academic medical center.

Competencies / Knowledge, Skills & Abilities

• Strong critical thinking and problem-solving skills required.
• Exceptional communication and interpersonal skills, both oral and written.
• Excellent multi-tasking and organizational skills, as well as the ability to make complex decisions in a fast-paced environment.
• Ability to learn quickly and understand new technical concepts and processes.
• Flexible and able to adapt to program growth and evolving responsibilities.
• Self-motivated and able to work in a team environment.
• Able to work well under pressure, especially when assisting involved stakeholders.
• Proficiency in Microsoft Suite (especially Excel, PowerPoint, Word, and Project).
• A strong working knowledge of Good Clinical Practices (GCP), U.S. Food and Drug Administration (FDA) rules and regulations in relation to clinical trials, National Institutes of Health (NIH) guidelines, International Council for Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) regulations in relation to clinical trials, and other universally accepted practices and procedures within clinician trial management.

Anticipated Pay Range

The starting salary range for this position has been established as $58,705 - $78,665.

The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

This position is not eligible for overtime compensation.

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: http://www.cu.edu/node/153125

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 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.