COG Research Foundation, LLC (Research Foundation) is a California 501(c)(3) entity founded in 2024 to serve as a fiscal sponsor to support research programs by providing legal, fiduciary, and administrative oversight for the program. The Research Foundation serves as the fiscal sponsor for the Children’s Oncology Group (COG).

COG, a member of the National Cancer Institute (NCI) National Clinical Trials Network (NCTN), is the world’s largest organization devoted exclusively to childhood and adolescent cancer research.  COG unites over 13,500 experts in childhood cancer at more than 220 leading children’s hospitals, universities, and cancer centers across the United States, Canada, Australia, New Zealand, and Saudi Arabia to conduct more than 50 active clinical trials, with approximately 9,500 participants registered each year in the fight against childhood cancer.

Position Summary

The Research Coordinator (RC) serves as the data management specialist on the study team (Protocol Coordinator, Research Coordinator, Study Builder and Statistician) for all assigned COG trials. This position is responsible for coordinating all aspects of data acquisition and management for assigned COG studies under the direction of the Study Chair, Study Statistician, COG/Scientific Committee leadership, and other staff responsible for implementing and conducting COG studies. This involves developing, testing, and implementing Case Report Forms (CRFs), data validations, and data management plans (DMP) for assigned COG studies.  It also involves monitoring the quality and timeliness of submitted study research data, overseeing subject enrollments/randomizations, conducting data cleaning activities, and coordinating central reviews within COG Electronic Data Capture systems (EDC) for all assigned studies.  The Research Coordinator is also required to amend CRFs per study needs, implementing the corresponding changes in the EDC system and DMP.

The COG Research Foundation, LLC is a 100% remote employer, though some travel may be required.  Employee must reside within the United States.

Full salary range for this position: $ 64,542 to $ 92,421 per year. The typical hiring range for this position is from $64,542 (minimum) to $78,482 (midpoint), based on 100% FTE. The starting salary is determined based on the candidate’s knowledge, skills, experience, as well as budget availability.

Essential Duties and Responsibilities

Case Report Form and Electronic Data Capture System Development:

• Review study protocols, especially section(s) pertaining to data collection and data management (i.e., treatment, supportive care, specimen submission, subject follow-up, etc.), ensuring that the database is designed to accurately capture the data required to meet the study aims.
• Coordinate with the study committee and study team on CRF development and study set-up timelines, ensuring study activation is within mandated deadlines.
• Design the CRFs and data validations (i.e., edit checks) required for assigned COG studies in collaboration with study committee and study team, ensuring consistency with the protocol, consent form documents and compliance with internal standard operating procedures (SOPs).
• Understand the fundamental, structure and workflow of Cancer Data Standards Registry and Repository (caDSR) Data Standard and request new common data elements (CDEs) as needed to capture essential research data for the study, or identify appropriate CDEs from existing repositories, following established guidelines and procedures.
• Construct CDISC/CDASH variables and fragment requests, ensuring adherence to established COG SOPs and guidelines while maintaining compliance with CDISC/CDASH standards.
• Lead CRF review activities with the study committee and study team, including presentation of CRFs to the COG CRF Review Committee for potential data collection and/or management issues.
• Perform User Acceptance Testing within the study EDC, including end user screen testing, refinement, documentation, and release of finalized electronic CRF forms adhering to the established development procedures.
• Create an integrated study data management plan (DMP) in conjunction with study team members, based on the study specific CRFs and data management standards.
• Review protocol amendments and determine required changes to the CRFs or study DMP. Coordinate with study team on amendment timelines, CRF change implementation, and site communications.

Data Management:

• Maintain and monitor the conduct of active trials, including managing subject enrollments/randomizations and opening, closing, or suspending studies, as required, according to established departmental SOPs and study DMPs.
• Monitor the quality of submitted research data through all EDC systems to evaluate timeliness of institutional data submissions and the completeness and internal consistency of data.
• Determine if modifications or enhancements to CRFs or data validations are required to prevent and correct data errors and omissions.
• Resolve data-related issues and queries that arise from the study site(s), and per routine and study specific data cleaning reports, in collaboration with the study team and in line with study DMP, and COG policies and procedures.
• Ensure Serious Adverse Events (SAE) reporting occurs per study specific protocol requirements, and within NCI guidance. Monitor consistency of serious adverse event data submissions versus submitted research data in EDC systems.
• Attend study team meetings, regularly provide study progress updates, and address any study data related issues.

Other Research Coordination:

• Organize and coordinate sample logistics for correlative biology studies involving the study site(s), laboratories, and study committee as necessary.
• Organize, coordinate, and monitor central reviews as determined by the protocol.
• Work with IT staff to address technical data collection problems.
• Perform related duties as required or assigned by the league leadership.

Qualifications 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.

Minimum Qualifications

• Two (2) years of human clinical trial research experience. A combination of relevant master’s degree and experience may be used to meet the two-year human clinical trial research experience requirement.
• Bachelor’s degree in a related field, or substitute with four additional years of relevant experience.

Other Qualifications

• Experience as a Clinical Data Manager or Clinical Research Coordinator is preferred.
• Experience in a comprehensive cancer center, cooperative group or pharmaceutical/biotechnology industry is highly desirable.
• Strong organizational skills with the ability to handle a variety of tasks and work independently.
• High level of PC literacy is needed, including broad knowledge of Microsoft Office software (MS Word, Excel, and PowerPoint).
• Excellent written and oral communication skills.
• Critical thinking and reasoning.

Fair Labor Standards Act (FLSA) Status

This position is classified as exempt based on the job duties. However, based on the FTE, salary level of the employee, or federal/state/local laws, the employee may be classified as nonexempt.

Why Join Us

This is a unique opportunity to be on the ground floor of a critical role within a mission-driven organization. This position will play a vital part in shaping the function of the Children’s Oncology Group, contributing to lasting change and making a difference in the lives of children and families impacted by cancer.

Benefits

Comprehensive benefit options include medical, dental, vision, 401(k), accrued Paid Time Off (PTO), Employee Assistance Program (EAP), Flexible Spending Account (FSA), cell phone and internet stipends, wellness stipend, paid holidays, and more. Employees who work 20 hours or more per week are eligible for these benefit options. These benefits are provided for informational purposes only and are subject to change in accordance with applicable policies and plan documents.

Equal Employment Opportunity Statement

COG Research Foundation, LLC is an Equal Employment Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and employees without regard to race, color, religion, creed, sex, pregnancy, national origin, age, ancestry, physical or mental disability or medical condition, genetic information, marital status, sexual orientation, gender identity or expression, military or veteran status, or any other characteristic protected by applicable federal, state, or local law.

COG Research Foundation, LLC seeks to recruit, develop, and retain the most talented people from a diverse candidate pool. Employment at COG Research Foundation, LLC is based on merit, competence, and qualifications, and we are committed to providing equal opportunities for training and advancement for all employees. COG Research Foundation, LLC is also committed to making our application process accessible to individuals with disabilities and will provide reasonable accommodation upon request. For further information regarding Equal Employment Opportunity, please feel free to access it here. 

ADA/Application Accommodation Statement 

COG Research Foundation, LLC is committed to providing reasonable accommodation to individuals with disabilities in the application and employment process, consistent with applicable law. Applicants who require accommodation are encouraged to make their request at the earliest opportunity to allow COG Research Foundation, LLC sufficient time to evaluate and respond to the request. Accommodation requests may be directed to the Recruitment Team at career@evolvehr.com.

This position falls under a contract with the Federal Government and is subject to the provisions in OMB Circular A-76 which prohibit contractors from performing inherently governmental functions. Specifically, employees placed in agency positions will not perform inherently governmental functions, nor supervise any personnel other than the contractor’s own staff, nor make final decisions or sign documents that commit the U.S. Government.