Research Coordinator and Study Builder
Posting Number: #033-21
Position Title: Research Coordinator and StudyBuilder
Closing Date: Until Filled
Location: Monrovia, CA
Children’s Oncology Group (COG), a project of PHI, is a National Cancer Institute (NCI) supported clinical trials cooperative group, and the world’s largest organization devoted exclusively to childhood and adolescent cancer research. Clinical research is conducted at more than 200 member institutions, which are leading children’s hospitals, universities, and cancer centers throughout the United States, Canada, Europe, Australia, and New Zealand. COG’s over 9,000 multi-disciplinary cancer researchers, affiliated with the network of member institutions, provide access to state-of-the-art therapies and the collective expertise of world-renowned pediatric specialists to children with cancer, regardless of where they live. Today, more than 90% of 14,000 children and adolescents diagnosed with cancer each year in the US are cared for at Children’s Oncology Group member institutions.
The Research Associate IV (RAIV) (Research Coordinator and Study Builder) coordinates all data collection and management activities for assigned Children’s Oncology Group (COG) studies during study development, initial set-up, study maintenance and conduct. This entails working closely with the study team, study committee, and other staff responsible for implementing and conducting COG studies.
The RAIV is responsible for creating, developing, and implementing Case Report Forms (CRFs), data validations, and data management plans (DMP) for assigned COG studies. The position takes the lead on study set-up, build, and maintenance of assigned COG studies within COG Electronic Data Capture (EDC) systems, including end-user screen testing in the User Acceptance Testing (UAT) environment. In addition, this role monitors the quality and timeliness of submitted study research data, overseeing patient enrollments, conducting data cleaning activities, and creating custom data reports for all assigned studies. The RAIV is required to amend CRFs per study needs, implementing the corresponding changes in the EDC system and DMP.
Essential Duties & Responsibilities
- Review and provide feedback on study protocols, especially section(s) pertaining to data collection and data management, 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 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, 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.
- Organize and lead CRF Review meeting calls presenting potential data collection and/or management issues as well as suggestions to enable an efficient study build.
- Set up the study framework in the EDC system (i.e., folders, forms, fields, matrices, and restrictions) and build edit checks and derivations per the finalized CRF specifications.
- As part of UAT, complete testing, refinement, documentation and release of electronic CRF forms adhering to the established development procedures.
- Review protocol amendments to determine if changes to the CRFs or study DMP are necessary. If necessary, draft CRF changes and coordinate appropriate review and approvals, implementing finalized changes in the EDC system as required.
- 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.
- Monitor the quality of submitted research data through all EDC systems to evaluate the 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.
- Participate in presentations/discussions regarding data management via teleconferences and at COG Group meetings.
- Bachelor’s degree in a relevant field or additional 4 years of equivalent experience.
- 5 years of related experience.
- Minimum 3 years of clinical research experience.
- 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, PowerPoint and Access).
- Excellent written and oral communication skills are essential.
- Critical thinking and reasoning skills.
- Experience as a Clinical Data Manager or Clinical Research Associate.
- Medidata RAVE, or similar EDC system study build experience.
- Experience in a comprehensive cancer center, cooperative group or pharmaceutical/biotechnology industry.
- This is a full-time (40 hours/week) position.
- This position is not eligible for telecommuting.
- To qualify for this position, applicants must be legally authorized to work in the United States.
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.
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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.