Trial Operations Quality Control Coordinator
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AI Summary
COG Research Foundation, LLC is a California 501(c)(3) entity that was founded in 2024 and designed to become the federal grantee organization for the Children's Oncology Group (COG). The 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 12,000 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 in the fight against childhood cancer.
COG conducts more than 100 active clinical trials, with approximately 12,000 patients registered on COG trials each year. 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.
Position Summary
Under the supervision of the Associate Director of Trial Operations, the Trial Operations Quality Control Coordinator provides guidance to the Leagues in maintaining high quality Protocol, Informed Consent, and supplemental documents throughout protocol development, amendments, and regular postings.
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: $70,296 to $101,911 per year. The typical hiring range for this position is from $70,296 (minimum) to $86,104 (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
- Maintain a working knowledge of Protocol Coordinator responsibilities and work instructions.
- Attend monthly Protocol Coordinator meetings, Quarterly Senior Protocol Coordinator meetings, Monthly Trial Operations meetings, Epi meetings, and monthly ROR Committee meetings.
- Provide quality control reviews on protocols, informed consent documents (ICDs), and supplemental documents across Leagues, as assigned.
- Provide feedback on consistency, clarity, and adherence to templates and standards to the assigned Protocol Coordinator for incorporation into protocols and related documents.
- Serve as the subject matter expert in the creation of Informed Consent Forms and Therapy Delivery Maps consistent with the organization’s standards.
- Present quality control review findings or issues regarding consistency and/or clarity in protocols, ICDs and other study documents to improve processes and templates.
- Provide quality control reviews of the weekly postings for consistency, clarity, and adherence to templates and standards to the Protocol Coordinator, Research Coordinator and the League Administrative Coordinators.
- Train new Protocol Coordinators and Research Coordinators in the weekly Protocol Posting Process.
- Assist the League Directors in the development and maintenance of departmental templates and SOPs.
- Provide coverage for Protocol Coordinators as assigned, based on temporary needs across leagues.
- Serve as the Protocol Coordinator of Epi trial proposals utilizing future contact consent.
- Represent Operations team on the Return of Results committee.
- Escalate questions or information to League Directors as appropriate.
- Travel to COG Group Meetings as needed to provide Protocol Coordinator coverage and attend Epi and Return of Results committee meetings.
- Perform related duties as required or assigned.
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 relevant experience in quality control and/or clinical trial protocol development, including familiarity with clinical trial components such as IND and IRB process, study methodology, informed consent, eligibility and adverse events.
- Bachelor’s degree in Life Sciences or a related field, or substitute with four (4) additional years of relevant experience.
Other Qualifications
- Demonstrated success and skill at researching, analyzing, and evaluating scientific information.
- Ability to work independently as well as collaboratively with staff and investigators.
- High level of computer literacy, including intermediate to advanced knowledge of Microsoft Word.
- Excellent verbal and written communications skills.
- Knowledge of word processing and medical terminology.
- Clinical research experience in development of investigator initiated trials, management of NCI- sponsored protocols, or related field is desired.
Preferred Qualifications
- Five (5) years of experience involving oncology protocol management, published manuscripts, grants or other documents related to scientific research is highly desired.
- Master’s degree in Life Sciences or related field is preferred.
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.
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