Nursing Clinical Research Coordinator COG

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 best of the best pediatric hospitals with #1 rankings in Colorado and the region 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 Nursing Clinical Research Coordinator is responsible for multiple research studies simultaneously, as a professional licensed liaison with the investigators, treating teams, pharmacy, laboratories, IRB's, Sponsors and sponsor agencies. Responsible for records and managing all phase of study protocols by sponsoring agencies ensuring compliance. Directly assists the Principal Investigator to supports the achievements of the research program and the study aims and objectives.

The COG (Children's Oncology Group) is a research program within the CCBD (Center for Cancer and Blood Disorders). This RN-CRC will work with the COG phase II/III clinical trial studies and some industry trials. These studies are clinical trial treatment, late effect, QOL and biology trials for children, adolescents, and young adults with newly diagnosed, recurrent/refractory oncology illnesses. The RN-CRC team member will work closely with providers, and nurses to coordinate study patient care.

The COG is a cooperative group specializing in pediatric clinical research inclusive of children, adolescents and young adults with cancer. The COG partners with research scientists from around the world in efforts to understand the causes of cancer and find more effective treatments for the children we care for.

Today, more than 90% of 16,000 children and adolescents diagnosed with cancer each year in the United States are cared for at Children's Oncology Group member institutions. COG's unparalleled collaborative efforts provide the information and support needed to answer important clinical questions in the fight against cancer. The Children's Oncology Group has nearly 100 active clinical trials open at any given time. These trials include front-line treatment for many types of childhood cancers, studies aimed at determining the underlying biology of these diseases, and trials involving new and emerging treatments, supportive care, and survivorship. The Children's Oncology Group research has turned children's cancer from a virtually incurable disease 50 years ago to one with a combined 5-year survival rate of 80% today.

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: RI-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 of being hybrid upon successful completion of department on-boarding/training, job performance and patient need.
*This position may have the occasional weekend or holiday requirement for specimen collection and/or processing.

• Education: Bachelors of Science in Nursing (BSN)
• Experience: 3 years nursing experience in related field
• Certification(s): BLS/CPR from the American Heart Association with at least 6 months left before expiration is required upon hire.
• Licensure(s): Registered Nurse (RN) licensure in the state of Colorado is required.

Preferred qualifications/experience:

• Coordination of all aspects of clinical trial management.
• Previous experience in COG pediatrics clinical trials.
• Excellent communications skills
• Experience with specimen processing and shipping
• Medical chart abstraction
• Expertise in identifying and grading Adverse Events (AE's).

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. Uses nursing professional knowledge to build orders in the EMR, (EPIC - Department specific).
2. Makes medical assessments of study participants, within the scope of Colorado nursing practice/licensure.
3. Educates clinical nursing staff, Clinical research coordinators (CRC's), and pts and families on research protocols
4. Assists clinical nursing staff and CRC's in educating patients/families in regards to clinical trials and ensuring patient compliance.
5. Assists clinical research coordinators (CRC's) to sign research orders within the EMR (EPIC) as required.
6. Releases research orders as allowed under CHCO nursing policies
7. Educates, trains and assists CRC's on an ongoing basis with nursing medical knowledge needs with regards to clinical trial requirements, complicated adverse events and Serious Adverse events (AE's and SAE's).
8. Provides expertise in patient care coordination and implementation of protocol requirements during onsite visits
9. Oversees the collection, data entry, and assists as needed with special procedures for study patients
10. Submits and/or provides assistance to CRCs with protocol submissions to the IRB(s) for review and approval throughout startup, continuing review, amendments and correspondence process by providing necessary medical/nursing components.
11. Submits and/or provides assistance to CRCs with preparation of PI applications to the FDA for eIND/IND/IDE approval.
12. May write and/or assist in writing protocols, consents, and other related protocol documents from the nursing medical perspective under the direction of the principal investigator.
13. Under the direction of the principal investigator assists with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs).
14. Collects and disseminates information to determine feasibility, recruitment and retention strategies.
15. Screens, schedules, and/or consents participants for clinical research programs and/or studies.
16. Maintains subject level documentation and prepares documents, equipment and/or supplies.
17. Prepares for and takes part in site initiation, monitoring, closeout visits, and document storage activities. Conducts and documents visits and testing/interviews per all regulatory and organizational protocols. Collects, prepares, processes, ships and maintains inventory of research specimens.
18. Prepares study records for FDA, OHAARP, CUCC and sponsor audits.
19. Employs strategies to maintain participant recruitment and retention rates and assists participants with individual needs.
20. Collects, prepares and/or processes Adverse Event (AE) information per protocol and provides input for AE reports. Complete and submit AE reports, per institution and sponsor-specific reporting requirements. Maintains or collaborates to maintain appropriate documentation.
21. Provides input for and assists with developing IRB related documents. Assists with identifying issues related to operational efficiency and shares results with management.
22. 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.
23. Participates in sponsor-required training. Obtains information for or coordinates operational plans for multiple research programs and/or studies.
24. Prepares for and participates in team meetings. Proactively includes others in decision making and escalates issues to management as necessary.
25. 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.
26. Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data. Recognize and report 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.
27. Recognize when data agreements or special regulatory requirements are necessary. May assemble the necessary parties to ensure that all requirement agreements are in place.
28. 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 per protocol. Assists with the development of data collection documents and instruments. Identifies issues related to data capture, collection or management and recommends solutions.
29. 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.
30. 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 & 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.

Communications: 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.

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.

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.