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Research Coordinator I Jobs
Company | Public Health Institute |
Address | United States |
Employment type | FULL_TIME |
Salary | |
Category | Non-profit Organizations |
Expires | 2023-06-18 |
Posted at | 11 months ago |
Position Summary
- Review 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.
- 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.
- 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.
- 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).
- 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.
- Coordinate with the study committee and study team on CRF development and study set-up timelines, ensuring study activation is within mandated deadlines.
- 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.
- Maintain and monitor the conduct of active trials, including managing patient enrollments/randomizations and opening, closing, or suspending studies, as required, according to established departmental SOPs and study DMPs.
- Resolve data-related issues and queries that arise from the study site(s), in collaboration with the study team and in line with COG policies and procedures.
- Determine if modifications or enhancements to CRFs or data validations are required to prevent and correct data errors and omissions.
- 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.
- Attend study team meetings, regularly provide study progress updates, and address any study data related issues.
- 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.
- Work with IT staff to address technical data collection problems.
- Perform related duties as required or assigned by the league leadership.
- 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.
- Bachelor’s degree in a related field, or substitute with four additional years of relevant experience.
- Minimum 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.
- Excellent written and oral communication skills.
- Critical thinking and reasoning.
- Experience as a Clinical Data Manager or Clinical Research Coordinator is preferred.
- 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).
- Experience in a comprehensive cancer center, cooperative group or pharmaceutical/biotechnology industry is highly desirable.
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