Clinical Research Program Lead

SUMMARY

The Clinical Research Program Lead is responsible for overseeing and coordinating research initiatives and major projects. This role will manage and advance the completion of our clinical research activities as an essential team member. In collaboration with cross-functional teams, the Clinical Research Program Lead will ensure that research initiatives are executed efficiently from inception to completion. The Clinical Research Program Lead is expected to demonstrate an extensive understanding of research operations, procedures, influence, project management and operating independently to enhance the progress of our organization's objective of providing innovative breakthroughs in the field of pediatric healthcare through the demonstration of an extensive understanding of clinical research methodology and project management. Working under the direction of the Principal Investigator(s) and in collaboration with the PICU Program Manager and study leadership teams, the Program Lead will oversee study implementation, staff training, regulatory and protocol compliance, participant recruitment and retention, data collection and reporting, site communication, and study progress. The Program Lead will ensure the highest standards of protocol implementation and data quality, identify and address operational barriers, coordinate study meetings and communications, and develop and implement processes to support efficient, consistent, and successful execution of research activities. This position presents onsite at least three days per week, with additional onsite time as needed for study execution, to support effective team communication and leadership.

PhysicaL Activity recoverY (PLAY) after critical lung injury in children

The PICU at Children's Hospital Colorado serves as the lead site for the PhysicaL Activity recoverY (PLAY) after critical lung injury in children study, a multi-site NIH-funded research proposal designed to improve understanding of physical recovery after pediatric critical illness. The Clinical Research Program Lead will oversee the coordination and successful execution of PLAY study activities across participating sites under the direction of the Principal Investigator. This role will serve as the primary operational contact for collaborating institutions and will be responsible for overall project management, study implementation, regulatory oversight, site communication, enrollment and follow-up activities at Children's Hospital Colorado, follow-up activities for participants enrolled at other sites, and monitoring study progress across all locations. The Program Lead will facilitate training and support for participating sites, coordinate study meetings and communications, manage study resources and timelines, and contribute to ongoing study development.

SPIN VINYL Study

The Clinical Research Program Lead will also coordinate all local study activities for Systematic Phenotyping and Endotyping in Viral Infections in the Young Lung (SPIN VINYL), a multi-center research initiative enrolling approximately 1,500 children ages 0-2 years hospitalized with lung disease due to viral infections. The study will collect biological specimens and granular clinical data during the inpatient stay, followed by longitudinal in-person and remotely collected assessments extending through school age. Working in collaboration with the PICU Program Manager and SPIN VINYL study leadership team, the Program Lead will oversee study execution at Children's Hospital Colorado including staff training, development and implementation of procedures to facilitate recruitment and participant retention, adherence to study protocols, and maintaining the highest standards of protocol implementation, data collection, and reporting. The Program Lead will also assist with participant screening and enrollment as needed and work closely with clinical and research teams to identify and address barriers to successful study execution.

SHIFT

Colorado Child Health Research Institute - Pediatric Intensive Care Unit

Monday - Friday

8:00 a.m. - 4:30 p.m.

Work hours may vary depending on the needs of the department.

Occasional weekend work may be needed to support study activities.

Hybrid eligible, depending on business needs.

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. Leads the development and implementation of strategic plans for clinical research programs, ensuring alignment with organizational goals. Additionally, plans, conducts, and manages research projects within federal, state, and organizational regulations, under the guidance of the clinical research manager and principal investigator.

2. Independently manages significant and key aspects of large complex research studies/programs or all aspects of multiple smaller integrated studies to ensure efficient operations.

3. Leads cross-functional teams of employed and affiliated research team members at Children's Hospital Colorado. Influences, guides, and promotes collaboration to achieve organization, department, or study goals.

4. Oversees the recruitment, selection, and retention of research participants, ensuring diverse and representative study populations.

5. Serves and provides guidance as a subject matter expert on the clinical research coordinator team, assuring study quality and compliance through quality assurance, control, and mentoring programs.

6. Contributes to team improvement and compliance by developing and maintaining Standard Operating Procedures (SOPs) and tools, and remaining current on industry trends, laws, and clinical research best practices.

7. Collaborates with principal investigators and stakeholders to define research objectives and deliverables.

8. Collaborates on the formulation, oversight, and administration of budgets, allocating resources effectively to ensure the successful execution of research initiatives. Maintains ongoing alignment of program scope with strategic business objectives by monitoring and evaluating program milestones. Ensures that program projects are completed in accordance with predetermined time and budget constraints. Proposes alterations as needed to alleviate potential hazards and optimize efficiency in pursuit of the desired outcomes or strategic goals.

9. Oversees data management for research projects. Develops and manages systems to organize, collect, report, and monitor data collection. Ensures the accurate and timely collection, analysis, and interpretation of research data.

10. Assists the principal investigators with the submission of progress reports, data updates and other documentation.

11. Fosters partnerships with external collaborators, including academic institutions and industry partners.

12. Collaborates with the Institutional Review Board (IRB) to obtain necessary approvals for research studies.

13. Facilitates communication and knowledge transfer among team members and relevant stakeholders.

14. Upholds ethical standards and confidentiality in all aspects of clinical research activities.

MINIMUM QUALIFICATIONS

Education: Bachelor's degree in a field related to human subject research, biology, or similar discipline.

Experience: Four (4) years of clinical research experience. Expert knowledge in clinical research operations, regulatory requirements, and ethical consideration in clinical research.

Equivalency: In lieu of bachelor's degree, professional experience will substitute on a year-for-year basis, in addition to the minimum years of experience.

Certification(s): None

Licensure(s): None

PREFERRED QUALIFICATIONS

• Master's degree in clinical research, public health, health sciences, or a related field.

• 5+ years of clinical research experience, preferably in pediatric, critical care, pulmonary, or other hospital-based research.

• Experience coordinating multi-site clinical research studies and serving as a primary operational contact for collaborating institutions.

• Experience with longitudinal studies involving participant recruitment, retention, and follow-up.

• Experience developing and implementing research workflows, training staff, monitoring protocol adherence, and ensuring data quality.

• Experience working with biological specimen collection and/or complex clinical research data.

• Experience working in a multidisciplinary academic medical center environment.

• Demonstrated ability to manage multiple priorities, timelines, and stakeholders in a complex research environment.

• Strong organizational, communication, and problem-solving skills.

• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) and Good Clinical Practice (GCP) training/certification preferred.

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

Annual Salary Range (Based on 40 hours worked per week): $81,019.02 to $121,528.53

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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