Protocol Coordinator

COG Research Foundation, LLC is a California 501(c)(3) entity founded in 2024 to serve as a fiscal sponsor for research programs, providing legal, fiduciary, and administrative oversight. COG is a member of the National Cancer Institute (NCI) National Clinical Trials Network (NCTN) and is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. It unites over 13,500 experts in more than 220 leading children’s hospitals, universities, and cancer centers across the United States, Canada, Australia, New Zealand, and Saudi Arabia, conducting more than 50 active clinical trials with approximately 9,500 participants registered each year. Position Summary The Protocol Coordinator (PC) serves as the protocol document specialist on the study team for all assigned COG trials. This position develops and maintains clinical research protocols, concepts, site communication memos, study training materials, and other study‑related documents under the scientific direction of the Study Chair and COG scientific committee leadership. The PC manages all internal and external review and approval processes throughout the trial, from early study concept to amendments, and coordinates with team members. Full salary range for this position: $64,542 to $92,421 per year. The typical hiring range is $64,542 (minimum) to $78,482 (midpoint) based on 100% FTE. The starting salary is determined by candidate experience, skills, and budget availability. The COG Research Foundation, LLC is a 100% remote employer; some travel may be required. Employees must reside within the United States. Essential Duties and Responsibilities Study Development Serve as the protocol document specialist within the study team. Manage the development of all documents related to clinical research protocols in conjunction with the study chair, study committee, COG scientific committee leadership, and the study team. Review supplemental protocol documents, including lab manuals, pharmacy manuals, and Electronic Medical Record templates. Coordinate all internal and external review and approval processes throughout the trial, from early study concept to study closure. Work with the study committee to ensure protocol changes related to National Coverage Analysis feedback are incorporated. Establish and communicate clear study development goals and deadlines to study chairs, pharmacists, statisticians, research coordinators, and other committee members to ensure study activation within Operational Efficiency Working Group (OEWG) timelines. Manage weekly study development calls with the study committee to facilitate protocol development discussions and lead study activation kick‑off calls. Design experimental design schemas and therapy delivery maps consistent with the protocol’s treatment plan. Maintain internal study records in study folders and track important events through COG tracking applications as outlined in departmental SOPs. Work with Research Coordinators to review draft Case Report Forms (CRFs) for consistency with the protocol and ensure specific requirements of the protocol are met. Follow all steps of PC SOPs regarding study development and deliver a final research document that incorporates all clinical details needed to treat subjects and research elements needed to answer study questions. Work with the League Administrative Assistants to prepare e‑friendly study documents that contain appropriate bookmarks and active links for website posting. Study Management Communicate with and facilitate communication between study chairs, study committee members, scientific committee chairs, institutional CRAs, and other cooperative groups as necessary. Respond to and resolve queries; take the lead on resolving issues related to study documents. Track information on reported problems regarding consistency and/or clarity in open protocols and work with the study team, study chairs, and disease chairs to resolve problems and amend the document as necessary. Identify the need for website postings to communicate updates for studies and prepare documents for posting. Stay informed of upcoming projects by attending study/disease committee meetings and team/league meetings; represent COG operations at COG scientific meetings. Perform related duties as required or assigned by league leadership. Writing Draft informed consent documents and youth information sheets according to COG guidelines. Maintain standard COG template language sections in protocol documents. Draft study‑specific supplemental documents as needed. Assist with other projects as needed. Perform other duties as 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 Experience in clinical research trials and clinical trial protocol development. Bachelor’s degree is required, or substitute with four additional years of relevant experience. Other Qualifications Familiarity with clinical trial components such as statistics, study methodology, informed consent, eligibility, and adverse events. 2–3 years writing experience involving protocols, published manuscripts, grants, or other documents related to scientific research is highly desired. Clinical research experience in life sciences or related field is desired. Demonstrated success and skill at researching, analyzing, and evaluating scientific information. Ability to work independently as well as collaboratively with group staff and investigators. High level of computer literacy, including intermediate to advanced knowledge of Microsoft Word. Excellent verbal and written communication skills. Knowledge of word processing and medical terminology. Masters in life sciences or related field is preferred. This position is classified as exempt based on the job duties. However, based on the FTE, salary level of the employee, or federal, state, or local laws, the employee may be classified as non‑exempt. Why Join Us This is a unique opportunity to be on the ground floor of a critical role within a mission‑driven organization. The PC will shape the function of the Children’s Oncology Group and help bring lasting change to the lives of children and families impacted by cancer. 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 benefits. 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. 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 View email address on click.appcast.io. 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. #J-18808-Ljbffr COG Research Foundation, LLC