The Public Health Institute (PHI) is an independent, nonprofit organization dedicated to promoting health, well-being, and quality of life for people throughout California, across the nation and around the world. As one of the largest and most comprehensive public health organizations in the nation, we are at the forefront of research and innovations to improve the efficacy of public health statewide, nationally, and internationally.

PHI was distinguished as one of the top 50 "Best Non-Profit Organizations to Work For" by the Non-Profit Times in a national search.

The Children's Oncology Group (COG), a National Cancer Institute supported clinical trials group, is the world's largest organization devoted exclusively to childhood and adolescent cancer research. The COG unites more than 10,000 experts in childhood cancer at more than 200 leading children's hospitals, universities, and cancer centers across North America, Australia, and New Zealand in the fight against childhood cancer. Our goal is to cure all children and adolescents with cancer, reduce the short and long-term complications of cancer treatments, and determine the causes and find ways to prevent childhood cancer.

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.

This is a remote regular full-time position.

Full salary range for this position: $62,968 to $90,167 per year. The typical hiring range for this position is from $62,968 (minimum) to $76,568 (midpoint), based on 100% FTE. The starting salary is determined based on the candidate's knowledge, skills, experience, as well as budget availability.

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.

• 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.

• 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.

PHI WORKFORCE MANDATORY COVID-19 VACCINATION POLICY

Per the PHI Workforce Mandatory COVID-19 Vaccination Policy, it is a condition of employment for all domestic based employees to be fully vaccinated for COVID-19, unless they are granted a reasonable accommodation under applicable law.

New hires need to provide proof of full vaccination prior to their start date or apply for an exemption/accommodation within three business days after their start date. Depending on the circumstances, new hires who do not comply with this Policy, or who cannot be reasonably accommodated, will either have their employment suspended or terminated. Candidates who are non-compliant will have their offers rescinded.

EEO Statement

The Public Health Institute is committed to a policy that provides equal employment opportunities to all employees and applicants for employment without regard to race, color, sex, religion, national origin, ancestry, age, marital status, pregnancy, medical condition including genetic characteristics, physical or mental disability, veteran status, gender identification and expression, sexual orientation, and to make all employment decisions so as to further this principle of equal employment opportunity. To this end, the PHI will not discriminate against any employee or applicant for employment because of race, color, sex, religion, national origin, ancestry, age, marital status, pregnancy, medical condition including genetic characteristics, physical or mental disability, veteran status, gender identification and expression, sexual orientation, and will take affirmative action to ensure that applicants are offered employment and employees are treated during employment without regard to these characteristics.

For further information regarding Equal Employment Opportunity, copy and paste the following URL into your web browser: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

ADA Statement:

The Public Health Institute is committed to providing access and reasonable accommodation in its services, programs, activities and employment for individuals with disabilities. To request disability accommodation in the application process, contact the Recruitment Team at least 48 hours in advance at Recruitment@phi.org.

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