Clinical Research Manager

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) direct supervision of finance-related activities, and 4) functioning as a study coordinator on ophthalmology trials. 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 ophthalmic 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, CO.

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 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: 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.

Diversity and Equity:

The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ+ community and all veterans. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications:

• Bachelor's degree in any field
  
  
  
  • A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis
  
  
  
  
• Five (5) years 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
• 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
• Demonstrated commitment and leadership ability to advance diversity and inclusion
• Knowledge of basic human anatomy, physiology, medical terminology
• Ability to interpret and master complex research protocol information

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 ashley.woodhouse@cuanschutz.edu

Screening of Applications Begins:

Immediately and continue until position is filled. For best consideration, apply by December 15, 2024.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as: $70,211-$89,309

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

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 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.