Protocol Coordinator

The company (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 (the company).

The company, 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.  The company 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

All staff are employed through the Research Foundation. This role will be in service to the company.

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 the company 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 the company/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.

The company 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

Study Development

• Serve as the protocol document specialist within the study team.

• Manage the development of all documents relating to clinical research protocols in conjunction with the study chair, study committee, the company 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 length of a trial, from early study concept to study closure.

• Work with the study committee to ensure protocol changes related to National Coverage Analysis feedback is appropriately incorporated.

• 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.

• Manage weekly study development calls with the study committee to facilitate protocol development discussion and lead study development and study activation kick-off calls.

• Design experimental design schemas and therapy delivery maps consistent with the treatment plan outlined in the protocol.

• Maintain internal study records in study folders and track important study events through the company tracking applications as outlined in departmental SOPs.

• 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.

• 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 the 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.

• Work with the study team to respond to and resolve queries. Take the lead on resolving issues relating 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 to be posted.

• Stay informed of upcoming projects by attending study/disease committee meetings and team/league meetings. Represent the company operations at the company scientific meetings.

• Perform related duties as required or assigned by the league leadership.

Writing

• Draft informed consent documents and youth information sheets according to the company guidelines.

• Maintain standard the company 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 (4) 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 of 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 communications skills.

• Knowledge of word processing and medical terminology.

Preferred Qualifications

• Masters in life sciences or related field is preferred.

Fair Labor Standard 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.

Background and Credit Checks

Employment with the company is contingent upon satisfactory completion of a pre-employment background check, which may include verification of criminal history, employment history, education, and other information as permitted by law. A credit check may be required for positions where it is relevant to and permitted based on the nature of the job duties, in accordance with applicable federal, state, and local laws. All background check results will be evaluated through an individualized assessment in accordance with applicable law. The company is an equal opportunity employer committed to fair chance hiring practices.

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

The company 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.

The company seeks to recruit, develop, and retain the most talented people from a diverse candidate pool. Employment at the company is based on merit, competence, and qualifications, and we are committed to providing equal opportunities for training and advancement for all employees. The company 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

The company 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 the company sufficient time to evaluate and respond to the request. Accommodation requests may be directed to the Recruitment Team at [link for members] .

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.