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Clinical Research Coordinator Surge

Clinical Research Coordinator Surge

Children's Hospital ColoradoAurora, CO, United States
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Job ID

91941

Location

Aurora

Position Type

Regular

Regular / Temporary

Regular

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Job Overview

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 our Surge research team supporting the Center for Cancer and Blood Disorders (CCBD), here at Children's Hospital Colorado! At the CCBD, discoveries from our laboratories are changing the way care is delivered for pediatric hematology, oncology and bone marrow transplants. Our scientists are recognized as national leaders in basic and clinical science research and have funding to support their research from numerous national hematology and oncology foundations. We believe that state-of-the-art treatment for pediatric cancer and blood disorders typically includes enrollment in a clinical trial. In fact, 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 extraordinary team at Children's Hospital Colorado is creating the future of child health, and we need top talent to do it. Join us!

Additional Information

Department : CCHRI-CCBD Clinical Research

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 allow for the occasional opportunity to work from home. This is dependent upon the successful completion of department on-boarding / training, offsite workload and job performance / competence.

Qualifications

  • 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.
  • Ideal applicant has previous oncology and / or medical experience.
  • Responsibilities

    POPULATION SPECIFIC CARE

  • Neonate -
  • 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.
  • 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
  • Salary Information

    Pay is dependent on applicant's relevant experience.

    Hourly 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.

    EEO Statement

    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.

    Colorado Residents : In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of attendance at or graduation from an educational institution. You will not be penalized for redacting or removing this information.

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