Open Rank Clinical Sciences Professional (Senior or Principal)

Job Summary:

Examples of Duties Performed - Senior Level:

• Set up and test equipment, software, websites, smart phrases, etc. before study start-up.
• Manage gift cards for study participants, ordering of supplies, and editing of study-related documents.
• Assist with and oversee the day-to-day operations of clinical trials and studies.
• Obtain the study subject's medical history and current medication information, review research protocol inclusion/exclusion criteria, and confirm eligibility of the subject to participate in the clinical trial.
• Perform the informed consent process or ensure that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required.
• Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews.
• Schedule subject participation in research clinical trials, coordinating the availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy).
• Collect, code, and analyze data obtained from research in an accurate and timely manner.
• Adhere to research regulatory standards.
• Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures, and other regulatory guidelines.
• Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities.
• Ensure that the necessary supplies and equipment for studies are in stock and working order.
• Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies.
• Independently perform study-related processes, procedures, and assessments as defined in the study protocol and in compliance with regulating bodies.
• Assist Team Leads, Supervisors, and/or management with the creation and implementation of processes and procedures and quality improvement initiatives.
• Act as a Primary Coordinator on multiple trials/studies.
• Assist and train junior team members.
• Assist with developing protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs), and Case Report Forms (CRFs). Maintains subject-level documentation and prepares documents, equipment, and/or supplies.
• Assist with identifying issues related to operational efficiency and share results with leadership.
• Collect information to determine feasibility, recruitment, and retention strategies. Employ, evaluate, and assist with the implementation of innovative solutions to maximize recruitment and retention.
• Serve as a resource and participate in study initiation and close-out duties.
• Oversee and provide informal leadership to the team members, including managing day-to-day priorities, evaluating and redistributing workloads temporarily, and mentoring staff.
• Provide input and feedback to leadership on team members' overall performance, performance evaluations, opportunities for development, and process improvement initiatives.
• Identify training and development opportunities for new and existing team members.
• Will oversee day-to-day operations of clinical research studies, in conjunction with the Clinical Research Manager and Directors of Research, including chart review and data collection for both prospective and retrospective clinical research studies in the Children's Hospital Colorado Emergency Department.
• Will perform and oversee all aspects of research enrollment.
• Shipping and managing samples.

Examples of Duties Performed - Principal Level:

As a Subject Matter Expert, Principal Professionals are expected to understand and perform Senior Level duties along with additional duties:

• Expertise in coordinating teams within large multicenter networks (e.g., PECARN and PEMCRC).

Expertise in coordinating complex randomized controlled trials (RCT).

• Participate in nodal and network-wide calls regarding studies:
  
  
  
  • Standardize and oversee study procedures across study teams across multiple sites.
  • Ensure compliance with central IRB and local requirements.
  • Identify and resolve conflicting requirements between central IRB and local institutional requirements.
  • Maintains central regulatory binder for multi-center studies.
  • Prepare and submit amendments, continuing reviews, and study submissions to central IRB.
  
  
  
  
• Respond to monitoring requests and lead monitoring visits with the central monitor.
• Expertise in protocol review and development for multicenter networks:
  
  
  
  • Review concepts and protocols during network meetings.
  • Sit on the network protocol review board to give feedback from a feasibility standpoint.
  
  
  
  
• Participation in multicenter network Research Coordinator committee:
  
  
  
  • Participate in Research coordinator advisory committee (RCAC) meetings.
  • Identifies areas of improvement within the network and proposes for discussion during RCAC meetings.
  • Applies for RCAC leadership positions.
  
  
  
  
• Procurement Cardholder:
  
  
  
  • Holds Procurement card for the section of Emergency Medicine.
  • Purchases supplies, gift cards, and services as needed by the section.
  
  
  
  

Work Location:

Why Join Us:

Onsite - this role is expected to work at Children's Hospital Colorado and is in Aurora, Colorado.

With 360 days of sunshine, plus mountains and abundant opportunities for hiking, skiing, biking, inner tubing, and other outdoor activities, the Colorado Front Range is the place to work and play! The Anschutz Medical Campus as a whole, which includes the University of Colorado Denver, ranks among the top 20 medical centers in the country. CU Anschutz has top-ranked clinical programs in family medicine and pediatrics, and the basic science and applied health research programs attract more than $1.4 billion in NIH funding annually. CU-Anschutz is home to the University of Colorado Hospital (UCH), The Children's Hospital of Colorado (CHCO), and the University of Colorado Schools of Medicine, Nursing, Dentistry, Pharmacy and Pharmaceutical Sciences, and Public Health, as well as a VA hospital, providing access to an array of possibilities to improve lives across a spectrum of ages and disease states.

The Department of Pediatrics, Section of Emergency Medicine conducts research at Children's Hospital Colorado on the Anschutz Medical Campus. With specialists in all aspects of emergency medicine, including anesthesia, asthma, bronchiolitis, sports injuries, bacterial and viral infections, and ultrasound use in the ED, plus additional specialized interests in areas such as child trafficking and STDs, the Emergency Department is overflowing with research opportunities. Our team also conducts simulation training for EMS providers throughout the State of Colorado, specializing in pediatrics.

The ED's robust research team conducts research activities from 7 AM to midnight, 7 days/week, running anywhere from 8-15 concurrent studies. The Section is a member of the prestigious Pediatric Emergency Care Applied Research Network (PECARN), an 18-member consortium that conducts research nationwide. In addition to conducting PECARN studies, we have funding from a variety of sources, including state, local, and foundation interests, as well as internal support for the valuable work we do.

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, ethnic minorities, 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:

• Bachelor's degree in any field.
• Two (2) years of clinical research or related experience.

• Bachelor's degree in any field.
• Three (3) years of clinical research or related experience.
  
  
  
  • Substitution (For All Levels): A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year-for-year basis.
  
  
  
  

Conditions of Employment:

• Must successfully pass a 10-panel drug test through Children's Hospital Colorado.*
• Must be willing and able to pass a national criminal and sex offender background check.
• COMIRB and HIPAA requirements for researchers must be completed before the first ED shift.
• Must be willing and able to abide by hospital, university, local, state, and federal regulations regarding human subject research.

*For questions regarding Children's Hospital drug testing requirements, please contact Children's Human Resources at 720-777-8598. Some positions may require testing if access to Children's Hospital or their systems is needed at any time during employment with the University. If drug testing is required, it will be listed in the job posting.

• Bachelor's degree in science or health-related field.
• Experience with electronic data capture systems (e.g., EMR or EHR and data management systems).
• Spanish proficiency.
• Emergency Medicine research experience.
• Three (3) years of clinical research or related experience.

• Bachelor's degree in science or health-related field.
• Experience with electronic data capture systems (e.g., EMR or EHR and data management systems).
• Spanish proficiency.
• Emergency Medicine research experience.
• Four (4) years of clinical research or related experience.
• Study coordination (regulatory, monitoring, etc) experience.

• Advanced 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, and medical terminology.
• Ability to interpret and master complex research protocol information.

How to Apply:

For full consideration, please submit the following document(s) in PDF format:

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: Gonzalo Lerner, Gonzalo.Lerner@cuanschutz.edu

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by November 20, 2024. Those who do not apply by this date may or may not be considered.

Anticipated Salary Range:

The hiring ranges for this position have been established as:

Senior Level: $56,169 to $71,447

Principal Level: $64,594 to $82,164

The above hiring ranges represent 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.