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.

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 9,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, New Zealand, and Europe in the fight against childhood cancer. An overarching principle of COG is to ensure that the organization’s structure is optimized to maximize the potential for research that improves the outcome for every successive generation of children with cancer.

Position Summary

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. S/he 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 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 patient enrollments/randomizations, conducting data cleaning activities, coordinating central reviews within COG Electronic Data Capture systems (EDC), and creating custom data reports 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. The RC II may be asked to serve as the COG data management representative and give presentations on study data management at COG Group meetings.

Full salary range for this position: $61,372 to $87,882 per year. The typical hiring range for this position is from $61,372 (minimum) to $74,627 (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 & Responsibilities

• Review and provide feedback on study protocols, especially section(s) pertaining to data collection and data management (i.e., patient treatment, supportive care, specimen submission, patient follow-up, etc.), ensuring that the database is designed to accurately capture the data required to meet the study aims.
• Coordinate with the study team on CRF development and study set-up timelines, ensuring study activation is within mandated deadlines. This includes identifying delays in study development and/or study set-up, and working to identify solutions.
• Design the CRFs and data validations (i.e., edit checks) required for assigned COG studies in collaboration with study team, ensuring consistency with the protocol, consent form documents and compliance with internal standard operating procedures (SOPs).
• Create 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.
• Circulate draft CRFs for review to study steam and lead CRF Review meeting calls presenting potential data collection and/or management issues.
• Utilize curation and Form Builder for eCRF design and as part of UAT, complete testing, refinement, documentation and release of finalized electronic CRF forms adhering to the established development procedures.
• Create an integrated study development and data management plan (DMP) in conjunction with study team members.
• Review protocol amendments to determine if changes to the CRFs or study DMP are necessary. Coordinate with study team on amendment timelines and site communications.
• If necessary with protocol amendments, draft CRF changes and coordinate appropriate review and approvals, discussing updates with study team, and implementing finalized changes in revised CRFs.
• Maintain and monitor the conduct of existing trials, including managing patient enrollments/randomizations and opening, closing, or suspending studies, as required, according to established departmental SOPs and study DMPs.
• Build custom data management reports based upon study committee requests and protocol requirements (i.e., utilize AQT, RDMS, Study Manager, etc.)
• 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 data validations are required to prevent and correct data errors and omissions.
• In collaboration with the study team and in line with COG policies and procedures, actively resolve data-related issues and queries that arise from the study site(s).
• 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 related issues.
• 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.
• Develop and maintain standard CRF templates for assigned disease area(s).
• Participate in presentations/discussions regarding data management via teleconferences and at COG Group meetings.
• Work independently and maintain proficiency in all RC related applications (Study Manager, SDE, RDMS, BRV, AQT, etc.).
• Perform other duties as assigned.

Minimum Qualifications

• Minimum 3 years of clinical research experience.
• Bachelor’s degree in science or quantitative field or four additional years of equivalent experience.

Preferred Qualifications

• Experience as a Clinical Data Manager or Clinical Research Associate 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, including broad knowledge of Microsoft Office software (MS Word, Excel, PowerPoint and Access).
• Excellent written and oral communication skills.
• Skills of 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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We’re so pleased the Public Health Institute is an organization you would like to work with. Do you have questions about this opportunity? If so, email our recruitment team at Recruitment@phi.org.