Clinical Research Coordinator Breathing Institute
Aurora, CO 
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Posted 11 days ago
Job Description
Job ID
86589
Location
Aurora, Colorado
Full/Part Time
Full-Time
Regular/Temporary
Regular
Why Work at Children's....

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.

Job Overview

The Clinical Research Coordinator 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.

The Airway Inflammation, Resilience & the Environment (AIRE) Program located at the Breathing Institute at Children's Hospital Colorado and led by Dr. Andy Liu conducts patient-oriented, team science research with top laboratory and exposure scientists, bioinformaticians and bioengineers to understand asthma causation, elucidate pathophysiologic disease mechanisms, and advance disease management and prevention so children with asthma can live normally and without fear of severe attacks.

This exciting opportunity will focus on recruiting pediatric study participants and coordinating and conducting clinical research visits for children with asthma and other pulmonary conditions for NIH funded projects and industry sponsored clinical trials.

Tasks for this position include telephone recruitment calls, conducting the informed consent discussion, following human subjects research protocols, coordinating and conducting in-person clinical assessments with breathing tests and biosample collection, processing biosamples in a laboratory setting, data entry and data quality monitoring, and active participation in team meetings regarding study implementation and process improvement.

Additional Information

Department: Pulmonary Medicine
Hours per week: 40, eligible for benefits
Shift: Monday - Friday, 8am-5pm, work hours may vary due to department needs.

Qualifications

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.
Spanish speaking preferred.

Responsibilities

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.

1.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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. Budgets/Financials - Participates in monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing.

Other Information

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.

Physical Requirements

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
Equal Employment Opportunity

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.


Salary Information

Annual Salary Range (Based on 40 hours worked per week): $44,410.53 to $66,615.79
Hourly Salary Range: $21.35 to $32.03

Benefits Information

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.


 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full or Part Time
Required Education
High School or Equivalent
Required Experience
Open
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