Research Coordinator I
Posting Number: #1111
Position Title: Research Coordinator I
Closing Date: Until Filled
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 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.
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.
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.
- Minimum two (2) years of clinical research experience. A combination of relevant master’s degree and experience may be used to meet the two-year clinical research experience requirement.
- 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 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.
- Bachelor’s degree in a related field, or you can substitute with four additional years of relevant experience.
- This is a full-time (40 hours/week) position.
- To qualify for this position, applicants must be legally authorized to work in the United States.
PHI WORKFORCE MANDATORY COVID-19 VACCINATION POLICY
Per the PHI Workforce Mandatory COVID-19 Vaccination Policy, effective January 10, 2022, it is a condition of employment for all employees to be fully vaccinated for COVID-19, unless they are granted a reasonable accommodation under applicable law. Employees starting on or before February 28, 2022 will need to provide proof of full vaccination up to 6 weeks after their start date or apply for an exemption/accommodation within three business days after their start date. Employees starting after February 28, 2022 will 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.
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