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 is responsible for participating in the day-to-day operations of assigned 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.

We are looking for a motivated, detail-oriented, highly organized, team-oriented person to join the Heart Institute Research team, here at Children's Hospital Colorado! As a leader in pediatric heart care, our Institute is the largest in the region, treating more than 20,000 patients each year. And because we're dedicated to training tomorrow's leaders, our heart fellowship program has educated hundreds of pediatric cardiologists who are changing the lives of children with heart disease across the country. We are also one of only eight stand-alone pediatric research centers in the country and we are committed to improving the lives of all kids and families with heart disease. Our extraordinary team at Children's Hospital Colorado is creating the future of child health, and we need top talent to do it. Join us!

Department: Research Institute
Hours per week: 40, eligible for benefits
Shift: Monday - Friday, 8am-4:30pm. Work hours may vary depending on needs of the department.

*This is a hybrid position.

Education: Bachelor's degree in a related field is required.
Equivalency: Associate's degree in a related field with a minimum of two (2) years of clinical research related experience may be considered in lieu of minimum education requirement.
Certification(s): Certification in Basic Life Support for the Healthcare Provider by the American Heart Association is required at the time of hire.

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.

• Submits studies for review and approval and provides status updates throughout the startup process. Assists regulatory team with Institutional Review Board (IRB) preparation and submission.
• Screens, schedules, consents participants in a variety of clinical research programs and/or studies. Explains the difference between clinical activities and research activities, risk and benefits of study participation to participants.
• Assists with developing or develops 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.
• Prepares for and takes part in site initiation, monitoring, closeout visits, and document storage activities. Conducts and documents visits and testing/interviews according to all regulatory and organizational protocols. Collects, prepares, processes, ships and maintains inventory of research specimens.
• Collects information to determine feasibility, recruitment and retention strategies. Employs strategies to maintain participant recruitment and retention rates and assists participants with individual needs.
• Collects, prepares and/or processes Adverse Event (AE) information per protocol and provides input for AE reports. May complete and submit AE reports, according to institution and sponsor-specific reporting requirements.
• Provides input for and assists with developing IRB related documents. Maintains or collaborates to maintain appropriate documentation.
• Assists with identifying issues related to operational efficiency and shares results with management.
• 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. May assist with the design of safeguards to ensure ethical conduct and to protect vulnerable populations.
• Participates in sponsor-required training. Obtains information for or coordinates operational plans for multiple research programs and/or studies.
• Prepares for and participates in team meetings. Proactively includes others in decision making and escalates issues to management as necessary.
• Assists with the development of proposals or protocols as directed. Identifies and communicates related shortcomings.
• Identifies various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of clinical research program and/or study aims. May participate in the determination of operational/statistical elements needed for conduct of clinical and translational programs and/or studies.
• 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. Adheres to and participates in the development and assessment of quality assurance. Assists with recognizing trends related to data quality and escalates as appropriate.
• Recognizes when data agreements or special regulatory requirements are necessary. May assemble the necessary parties to ensure that all required agreements are in place.
• Utilizes 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. Identifies issues related to data capture, collection or management and recommends solutions.
• Assists with management of Investigational Products (IP). Utilizes required system for handling, dispensing and documenting IP for sponsored protocols. Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level.
• Participates in monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing.

KNOWLEDGE, SKILLS & ABILITIES

• Ability to develop an understanding of and to utilize medical and clinical research related terminology.
• Ability to understand basic concepts of clinical research program and study design.
• Ability to recognize and employ professional guidelines and code of ethics related to the conduct of clinical research.
• Ability to maintain a general awareness of best practices, trends and changes in the clinical research profession.

SCOPE AND 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.

Ability to Perform Essential Functions of the Job

• 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.