Clinical Research Manager – Clinical Trials

Job Summary:

The Department of Ophthalmology seeks a full-time Clinical Research Manager. The position is responsible for all aspects of clinical research for both investigator-initiated and sponsored trials. Main components of the job include 1) management of all departmental human-subject trials and the study coordinator team 2) administration of the internal and external regulatory processes 3) support of finance-related activities in partnership with the department finance team and 4) functioning as a trainer for study coordinators and backup coordinator as needed. Tasks including project development such as editing protocols writing consent forms and subject materials and interpretation of protocols for the preparation of source documents analysis of results and contribution to publications. Regulatory tasks include local and central IRB submissions maintaining clinical trial records FDA submissions and acting as a liaison between industry grants and contracts principal investigators and the department administrator. Study coordinator activities include recruitment and enrollment of participants performing study visits managing subject related activities such as travel data entry and coordination of activities with the CRO/sponsor A thorough knowledge of ophthalmology terms equipment testing procedures and surgical procedures is required to function as a resource to the study team faculty and industry.

Key Responsibilities:

Serves as administrative lead for clinical trials.

Maintains clinical trial finance records to ensure timely billing and payment by sponsors.

Provide oversight direction and leadership for all clinical research operations within unit

Hire train supervise coach and direct team members

Monitor and actively direct workload within unit

Provide oversight of Good Clinical Practice (GCP) in all studies

Develop program/project goals and communicate goals and outcomes with a variety of stakeholders

Participate in tactical and strategic program/project development and planning

Participate in program/project budget development processes including grant writing and submission processes and regularly reviews to ensure alignment

Lead and participate in program/project start up and close out functions

Work Location:

Onsite this role is expected to work onsite and is located in Aurora Colorado.

Why Join Us:

The Department of Ophthalmology is housed in the Sue Anschutz-Rodgers Eye Center on the Anschutz Medical Campus. This state-of-the-art facility is one of the largest eye centers in the country and serves not only patients in the Rocky Mountain region but also patients all over the world.

The technological innovations conceived and developed by departmental faculty have changed the practice of eye care throughout the world. Our educational programs train the next generation of leaders in ophthalmology. Our specialists have developed national and international reputations for excellence in routine and complex ophthalmic care. We have invested heavily in tracking our clinical outcomes and we are proud that our clinicians perform at the highest levels in their respective fields.

The mission of the Department of Ophthalmology is to be a nationally recognized department of ophthalmology by providing exemplary patient care founded on educational leadership innovative research and high ethical standards.

Why work for the University

We haveAMAZINGbenefits 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: 10/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:

• Bachelors degree in any field

  • Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelors degree on a year-for-year basis.

  • AND Five (5) years of clinical research or related experience

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Bachelors degree in science or a related field

• Prior supervisory or management experience in a clinical research setting

• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)

• Three or more years of clinical research experience in an ophthalmic practice setting.

• Certification as a Certified Ophthalmic Technician (COT) or higher with a minimum of 2 years of relevant ophthalmic medical experience may be substituted for degree

• Classroom and medical experience in ophthalmology to include refraction tonometry ETDRS vision testing pupillary assessment and ability to perform basic slit lamp exam is required.

• Current Clinical Research Certification (CCRC CCRA CCRP) or meets criteria to sit for exam within one year.

• Non-clinical OD or MD with clinical research experience

Knowledge Skills and Abilities:

• Ability to set goals motivate team members to achieve results

• Knowledge of supervisory techniques management principles and organizational leadership

• Expert knowledge and understanding of federal regulations and Good Clinical Practice (GCP)

• 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 medical terminology

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

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: Ashley Woodhouse

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration apply by October 1 2025.

Anticipated Pay Range:

The starting salary range for this position has been established at

• $71244 - $90622

The above salary range (or hiring range) represents the Universitys 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 .

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 othervaccine 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 addition if you work in certain research areas or perform certain safety sensitive job duties you must enroll in theoccupational health medical surveillance program.