Protocol Coordinator

<div class="content-intro"><p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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). </span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p></div><p><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 14pt;">Position Summary</span></strong></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The Protocol Coordinator (PC) serves as the protocol document specialist on the study team (Protocol Coordinator, Research Coordinator, Study Builder and Statistician) for all assigned COG trials. This position is responsible for developing and maintaining 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. This includes managing all internal and external review and approval processes throughout the trial, from early study concept to amendments, and coordinating with fellow team members.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">The COG Research Foundation, LLC is a 100% remote employer, though some travel may be required.  Employee must reside within the United States.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</span></p> <p><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 14pt;">Essential Duties and Responsibilities</span></strong></p> <h3><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Study Development</span></h3> <ul> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Serve as the protocol document specialist within the study team.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Manage the development of all documents relating to clinical research protocols in conjunction with the study chair, study committee, COG scientific committee leadership and the study team.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Review supplemental protocol documents, including lab manuals, pharmacy manuals, and Electronic Medical Record templates.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Coordinate all internal and external review and approval processes throughout the length of a trial, from early study concept to study closure.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Work with the study committee to ensure protocol changes related to National Coverage Analysis feedback is appropriately incorporated.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Establish and communicate clear study development goals and deadlines to be met by study chairs, pharmacists, statisticians, research coordinators, and other members of the study committee in order to ensure study activation within Operational Efficiency Working Group (OEWG) timelines.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Manage weekly study development calls with the study committee to facilitate protocol development discussion and lead study development and study activation kick-off calls.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Design experimental design schemas and therapy delivery maps consistent with the treatment plan outlined in the protocol.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Maintain internal study records in study folders and track important study events through COG tracking applications as outlined in departmental SOPs.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Work with team Research Coordinators to review draft Case Report Forms (CRFs) for consistency with the protocol document and ensure specific requirements of the protocol are met.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Work with the League Administrative Assistants to prepare e-friendly study documents that contain the appropriate bookmarks and active links for website posting.</span></li> </ul> <h3><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Study Management</span></h3> <ul> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Communicate with and facilitate communication between study chairs, study committee members, scientific committee chairs, institutional CRAs and other cooperative groups as necessary.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Work with the study team to respond to and resolve queries. Take the lead on resolving issues relating to study documents.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Identify the need for website postings to communicate updates for studies and prepare documents to be posted.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Stay informed of upcoming projects by attending study/disease committee meetings and team/league meetings. Represent COG operations at COG scientific meetings.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Perform related duties as required or assigned by the league leadership.</span></li> </ul> <h3><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Writing </span></h3> <ul> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Draft informed consent documents and youth information sheets according to COG guidelines.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Maintain standard COG template language sections in protocol documents.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Draft study-specific supplemental documents as needed.</span></li> <li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Assist with other projects as needed.</span></li> <li><span style="font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt;">Perform other duties as assigned</span>.</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif;"><strong><span style="font-size: 14pt;">Qualifications</span></strong> </span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</span></p> <h3><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Minimum Qualifications</span></h3> <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience in clinical research trials and clinical trial protocol development.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Bachelor’s degree is required, or substitute with four additional years of relevant experience.</span></li> </ul> <h3><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Other Qualifications</span></h3> <ul> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Familiarity with clinical trial components such as statistics, study methodology, informed consent, eligibility, and adverse events.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">2-3 years writing experience involving protocols, published manuscripts, grants or other documents related to scientific research is highly desired.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Clinical research experience in life sciences or related field is desired.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Demonstrated success and skill at researching, analyzing, and evaluating scientific information.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to work independently as well as collaboratively with Group staff and investigators.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">High level of computer literacy, including intermediate to advanced knowledge of Microsoft Word.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Excellent verbal and written communications skills.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Knowledge of word processing and medical terminology.</span></li> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Masters in life sciences or related field is preferred.</span></li> </ul> <p><span style="font-size: 14pt;"><strong><span style="font-family: arial, helvetica, sans-serif;">Fair Labor Standards Act (FLSA) Status</span></strong></span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</span></p><div class="content-conclusion"><h2><span style="font-family: arial, helvetica, sans-serif;">Why Join Us</span></h2> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p> <h2><span style="font-family: arial, helvetica, sans-serif;">Benefits</span></h2> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p> <h2>Equal Employment Opportunity Statement</h2> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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 <a href="https://www.eeoc.gov/">here</a>. </span></p> <h2>ADA/Application Accommodation Statement </h2> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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 <a href="mailto:career@evolvehr.com"><strong>career@evolvehr.com</strong></a>.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p> <p> </p></div>

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