Clinical Research Coordinator CCBD

Here, it's different. Come join us.

Children's Hospital Colorado has defined and delivered pediatric healthcare excellence for more than 100 years.

Here, the nation's brightest nurses, physicians, scientists, researchers, therapists, and care providers are creating the future of child health. With an optimist's outlook, a trailblazing spirit, and a celebrated history, we're making new strides every day.

We've been Magnet-designated four times by the American Nurses Credentialing Center and are consistently recognized among the nation's top 10 pediatric hospitals by U.S. News & World Report.

As a national leader in pediatric care, we serve children and families from all over the nation. Our System of Care includes four pediatric hospitals, 11 specialty care centers, 1,300+ outreach clinics and more than 10,000 healthcare professionals representing the full spectrum of pediatric care specialties.

Here, we know it takes all of us, every role, to deliver the best possible care to each child and family we treat.

That's why we build our teams toward a foundation of equity in access, advancement, and opportunity. We know teams of individuals with different identities and backgrounds can nurture creativity and innovation. We know we can see, treat, and heal children better when our team reflects the diversity of our patient population. We strive to attract and retain diverse talent because we know a truly inclusive and equitable workforce will help us one day realize our most basic calling: to heal every child who comes through our doors.

A career at Children's Colorado will challenge you, inspire you, and motivate you to make a difference in the life of a child. Here, it's different.

The Clinical Research Coordinator CCBD is responsible for participating in the day-to-day operations of routine, minimally complex clinical research programs and/or studies conducted by Principal Investigators (PIs) at the University of Colorado Anschutz Medical Campus. Performs a variety of administrative and operational duties involved in the collection, compilation, documentation, and review of clinical research data. Supports the achievement of research program and/or study objectives. Works under close supervision, receiving instruction, guidance and direction from Senior CRC, Clinical Research Supervisor and/or leadership team.

We are seeking a motivated, detail-oriented, highly organized, and team-oriented person to join our Center for Cancer and Blood Disorders (CCBD) research team. The ideal candidate thrives in a collaborative environment and is passionate about advancing pediatric oncology and hematology care through innovative clinical research. At CCBD, we believe that state-of-the-art treatment for pediatric cancer and blood disorders typically includes enrollment in a clinical trial. Research shows that children who participate in clinical trials have better survival rates than children who do not. Here, we're not just leading transformative research for the sake of innovation. We're using it to pioneer treatments with the hope of eradicating childhood disease and changing pediatric medicine - giving all kids a chance at a healthier future.

Our CCBD team cares for those patients who have recurrent cancer, cancer that hasn't responded to typical treatment or cancers without a known cure. We provide consultation for these patients for possible clinical trials and care for patients being treated on phase one or phase two clinical trials. The trials available through the CCBD program study new treatments to learn about the safest dose, the best way to give the treatment and how these treatments work best.

Department: CCHRI-CCBD Clinical
Hours per week: 40, eligible for benefits
Shift: Monday - Friday, 8am to 4:30pm. Work hours may vary due to department needs. This position may have the possibility to be a hybrid role upon successful completion of onboarding/training and job performance/competence. Although rare, there is a slight possibility that this role may have weekend coverage.

• Education: Bachelor's degree in a related field is required.
• Equivalency: High School diploma or GED, and four (4) years of clinical, clinical support, or clinical research related experience may be considered in lieu of minimum education requirement.
• Previous research experience preferred.
• Previous oncology experience is also preferred.

POPULATION SPECIFIC CARE

• Neonate - <30 days
• Infancy - >30 days to 1yr
• Toddlers - >1yr to 3yrs
• Pre-Schoolers - >3yrs to 5yrs
• School age - >5yrs to 13yrs
• Adolescent - >13yrs to 18yrs
• Adult - >18yrs to 65yrs

ESSENTIAL FUNCTIONS
An employee in this position may be called upon to do any or all of the following essential functions. These examples do not include all of the functions which the employee may be expected to perform.

• Documentation/Data Collection - Prepares and takes part in site initiation, monitoring, closeout visits, document storage activities, and related training. May assemble the necessary parties to ensure that all required agreements are in place. Utilizes and assists senior team members on electronic data capture systems, technologies, and software necessary for clinical research program and/or study operations. Scores tests, enters data, and completes required forms accurately and according to protocol. Assists with the development of data collection documents and instruments, maintains subject level documentation, and prepares documents, equipment and/or supplies identifies issues recommends solutions.
• Regulatory - Submits assigned studies for review and approval and provides status updates throughout the startup process. Assists regulatory team with Institutional Review Board (IRB) preparation and submission.
• Study Participation - Screens, schedules, consents participants in assigned clinical research programs and/or studies. With guidance, explains the difference between clinical activities and research activities, risk and benefits of study participation to participants. Engages with senior study team to maintain participant recruitment and retention rates and assists with participants with individual needs, collects information to determine feasibility. Collects information to determine feasibility, recruitment, and retention strategies. Collects, prepares, processes, ships, and maintains inventory of research specimens.
• Protocol - Trains in developing protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Conducts and documents visits and testing/interviews according to all assigned regulatory and organizational protocols. Trains in completing and submitting AE reports, according to institution and sponsor-specific reporting requirements. Assists with the development of proposals or protocols as directed. Identifies and communicates related shortcomings. Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level.
• Human Subject Research Protection - Maintains compliance with institutional requirements and policies. Develops and maintains a familiarity with the ethical conduct of research and safeguards needed when conducting clinical research. Trains in the design of safeguards to ensure ethical conduct and to protect vulnerable populations and participates in sponsor required training. Trains on professional guidelines and code of ethics.
• Team Coordination - Proactively includes others in decision making and escalates issues to leadership as necessary. Learns various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of clinical research program and/or study aims.
• Quality Assurance - Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data. Recognizes and reports vulnerabilities related to security of physical and electronic data. Assists with recognizing trends related to data quality and escalates as appropriate. Adheres to and participates in the development and assessment of quality assurance. Assists with identifying issues related to operational efficiency and shares results with team members.
• Budgets/Financials - Participates in monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing.

SCOPE & LEVEL

Guidelines: Trains in the field and assists higher level team members to acquire learning through practical experience.

Complexity: Performs routine and/or basic tasks common to the field. Procedures, methods, and techniques to be used are well established with options to be considered well defined. Tools, work aids and materials to be used are specified.

Decision Making: Duties assigned are primarily routine, repetitive, and restricted in intricacy with little or no discretion in how they are carried out.

Communication: Contact with team members, clients, or the public where factual information relative to the organization or its functions are received, relayed, or a service rendered according to established procedures or instructions.

Supervision Received: Under close supervision, the team member receives training to develop skills and abilities in a specific line of work or general occupational area. Work product is subject to close, continuous inspection.

PHYSICAL REQUIREMENTS

Audio-Visual: Color Discrimination: Good

Audio-Visual: Depth Perception: Good

Audio-Visual: Far Vision: Good

Audio-Visual: Hearing: Good

Audio-Visual: Near Vision: Good

General Activity: Sit: 2-4 hrs. per day

General Activity: Stand/Walk: 2-4 hrs. per day

Motion: Bend: Up to 1/3 of time

Motion: Carry: Up to 1/3 of time

Use of Hands/Feet: Both Hands - Gross Motor Function

Use of Hands/Feet: Both Hands - Precise Motor Function (Or Fine Manipulation)

Weight Lifted/Force Exerted: Up to 25 pounds: Up to 1/3 of time

WORK ENVIRONMENT

Equipment: Telephone, computers, reading reports/graphs

Exposure: Exposure to blood/body fluid: Regular/Frequent

Exposure: Exposure to chemicals: Occasional

Exposure: Exposure to infectious diseases: Occasional

Exposure: Exposure to radiation: Occasional

Exposure: Exposure to skin irritations: Occasional

Mental and Emotional Requirements: Handles multiple priorities effectively

Mental and Emotional Requirements: Manages stress appropriately

Mental and Emotional Requirements: Works alone effectively

Mental and Emotional Requirements: Works in close proximity to others and/or in a distracting environment

Mental and Emotional Requirements: Works with others effectively

Mental and Emotional Stress: Managing workload and system issues

Mental Stress: Multi-tasking, meeting deadlines, prioritizing

It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law or regulation. Be aware that none of the questions are intended to imply illegal preferences or discrimination based on non-job-related information.

The position is expected to stay open until the posted close date. Please submit your application as soon as possible as the posting is subject to close at any time once a sufficient pool of qualified applicants is obtained.

Here, you matter. As a Children's Hospital Colorado team member, you will receive a competitive pay and benefits package designed to take care of your needs that includes base pay, incentives, paid time off, medical/dental/vision insurance, company provided life and disability insurance, paid parental leave, 403b employer match (retirement savings), a robust wellness program, and access to professional development tools, including an education benefit to help you advance your career.

As part of our Total Rewards package, Children's Colorado offers an annual employee bonus program that rewards eligible team members based on organizational performance. If organizational goals are met for the year, the bonus is paid out the following April.

Children's Colorado delivers annual base pay increases to eligible team members based on their performance over the previous year.