Nursing Clinical Research Coordinator Oncology

The Experimental Therapeutics Research Program is recruiting a skilled and highly motivated Research Nurse to support a diverse portfolio of early-phase pediatric oncology clinical trials. This position plays a central role in coordinating protocol activities, ensuring participant safety, maintaining regulatory compliance, and delivering high-quality research nursing care. The ideal candidate brings strong clinical judgment, exceptional communication skills, and a commitment to improving outcomes for children with cancer through research.

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.

Additional Information:

Department: CCHRI-CCBD Clinical
Hours: 40 hours/week
Shift: Monday - Friday, 8am-4:30pm. Work hours may vary based on the needs of the department.

*This is a hybrid position.

Duties & Responsibilities

• Uses nursing professional knowledge to build orders in the EMR, (EPIC - Department specific).
• Makes medical assessments of study participants, within the scope of Colorado nursing practice/licensure.
• Educates clinical nursing staff, Clinical research coordinators (CRC's), and pts and families on research protocols
• Assists clinical nursing staff and CRC's in educating patients/families in regards to clinical trials and ensuring patient compliance.
• Assists clinical research coordinators (CRC's) to sign research orders within the EMR (EPIC) as required.
• Releases research orders as allowed under CHCO nursing policies
• 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).

• Provides expertise in patient care coordination and implementation of protocol requirements during onsite visits

• Oversees the collection, data entry, and assists as needed with special procedures for study patients

• 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.
• Submits and/or provides assistance to CRCs with preparation of PI applications to the FDA for eIND/IND/IDE approval.
• 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.
• 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).
• Collects and disseminates information to determine feasibility, recruitment and retention strategies.
• Screens, schedules, and/or consents participants for clinical research programs and/or studies.
• 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 per all regulatory and organizational protocols. Collects, prepares, processes, ships and maintains inventory of research specimens.

• Prepares study records for FDA, OHAARP, CUCC and sponsor audits.
• 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. Complete and submit AE reports, per institution and sponsor-specific reporting requirements. Maintains or collaborates to maintain appropriate documentation.
• Provides input for and assists with developing IRB related documents. 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.
• 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. 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.
• Recognize when data agreements or special regulatory requirements are necessary. May assemble the necessary parties to ensure that all requirement 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 per 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.
  

Minimum Qualifications

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.

Salary Information
Pay is dependent on applicant's relevant experience.

Hourly Range: $38.34 to $57.52

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.