Sr. Clinical Research Coordinator

We are looking for a motivated, highly organized, team-oriented person to join our Children's Oncology Group Research Team here at Children's Hospital Colorado! The Center for Cancer and Blood Disorders (CCBD) at Children's Hospital Colorado has one of the best pediatric hematology, oncology (cancer care) programs in the country. Children's Hospital Colorado is one of the highest accruing participating institutions within the Children's Oncology Group Consortium.

We treat kids, adolescents and young adults from birth through mid-20s with cancer and non-malignant blood disorders. We provide access to breakthrough clinical trials to the patients and families we serve and 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!

The Clinical Research Coordinator Senior is a seasoned coordinator who can work across multiple complex modalities and is responsible for participating in the day-to-day operations of complex, multi-site clinical research programs and/or studies conducted by Principal Investigators (PIs) at Children's Hospital Colorado / 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. Reviews medical charts via EPIC EMR for reportable adverse events/serious adverse events for patients assigned. Expected to provide mentorship and be involved in onboarding new team members withing the CCBD department. Facilitates the accomplishment of research programs and/or study goals by collaborating with multiple internal and external stakeholders. Works independently and leads others in navigating the clinical research environment and participates in a variety of departmental and/or divisional initiatives. Works under minimal supervision.

Additional Information:

Location: CCHRI - CCBD Clinical, Aurora Anschutz

Shift/Hours: Monday - Friday 0800 - 1630. Work hours may vary due to department needs. 40 hours per week, eligible for benefits.

Duties & Responsibilities

• Documentation/Data Collection - Prepares and takes part in site initiation, monitoring, closeout visits, and document storage activities, and related training, creation of SOPs and implementation of operational plans. Assembles the necessary parties to ensure that all required agreements are in place. Utilizes and assists with training 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. Leads the development of data collection documents and instruments, maintains subject level documentation, and prepares documents, equipment and/or supplies, identifies issues recommends solutions.

• Regulatory - Identifies and liaises with various regulatory partners (IRB, compliance, legal) as needed for clarity in effectively supporting research operations. Identifies gaps and participates in policy, standard operating procedures and guideline development as required to enhance research operations in the CHRE. 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.

• Study Participation - 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. Conducts difficult, sensitive conversations with patients/families. Employs, evaluates, and assists with the implementation of innovative solutions to maximize recruitment and retention, and assists participants with individual needs. Collects information to determine feasibility, recruitment, and retention strategies. Collects, prepares, processes, ships, and maintains inventory of research specimens.

• Protocol - Develops and optimizes 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 regulatory and organizational protocols. Completes and submits along with regulatory team the AE reports, according to institution and sponsor-specific reporting requirements. Serves as a resource regarding institutional and sponsor-specific reporting requirements. Assists with the development of proposals or protocols. Identifies and communicates related shortcomings. Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level.

• 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. Serves as a resource and assists with the design of safeguards to ensure ethical conduct and to protect vulnerable populations and participates in sponsor required training. Serves as a resource and trainer for issues related to professional guidelines and code of ethics. Identifies and facilitates resolution of potential problems and risks to the participant, study and/or institution.

• Team Coordination - Leads team meetings. Proactively includes others in decision making and escalates issues to leadership as necessary. Provides significant contribution and influence upon research work, activities and/or productivity of study teams. Leads a committee or task force under direction of a supervisor. Leads scientific or programmatic presentations. Identifies various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of clinical research program and/or study aims. Implements with leadership team on the operational elements needed for the conduct of clinical and translational programs and/or studies.

• Quality Assurance - Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data and assists management with resolution. Recognizes and reports vulnerabilities related to security of physical and electronic data. Assists with recognizing trends related to data quality and develops and implements retraining as appropriate. Adheres to and oversees the development and assessment of quality assurance processes. Identifies issues related to operational efficiency and shares results with team members and management. Recognizes when data agreements or special regulatory requirements are necessary and acts as a resource and mentor to determine when special contracts are necessary and escalates to stakeholders. Develops systems and/or frameworks for quality assurance processes in collaboration with leadership.

• Budgets/Financials - Participates in and provides oversight to monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing. Comprehensive understanding of institutional process for the development of budgets. Proactively identify gap deficits and escalating.

• Mentoring/Coaching - Provides oversight, training and coaching to team members working in the clinical research environment, specifically with the concepts of program and/or study design.

Minimum Qualifications

• Degree: Bachelor's degree in a related field is required.

• Experience
  • Required:Three (3) years of clinical, clinical support, and or clinical research related experience.
• Equivalency
  • Associates degree + 5 years experience above stated requirements may substitute for bachelor's degree.
• Preferred
  • Three (3) years experience working in Phase I-IV clinical oncology trials.
  • Experience working with Children's Oncology Group

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

Hourly Range: $25.95 to $38.93

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.