•Create and test Case Report Forms for study protocols•Review and provide feedback on study protocols.•Coordinate with the study team on CRF development and study set-up timelines.•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 andprocedures.•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 theestablished development procedures. •Create an integrated study development and data management plan (DMP) in conjunction withstudy 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. •Maintain and monitor the conduct of existing trials, including managing patientenrollments/randomizations and opening, closing, or suspending studies, as required, accordingto established departmental SOPs and study DMPs.•Monitor the quality of submitted research data through all EDC systems to evaluate timeliness ofinstitutional data submissions and the completeness and internal consistency of data. Determineif modifications or enhancements to data validations are required to prevent and correct dataerrors and omissions.•In collaboration with the study team and in line with COG policies and procedures, actively resolvedata-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 versussubmitted research data in EDC systems.•Attend study team meetings, regularly provide study progress updates, and address any studyrelated issues.

•Review and provide feedback on study protocols.•Coordinate with the study team on CRF development and study set-up timelines.•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 andprocedures.•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 theestablished development procedures. •Create an integrated study development and data management plan (DMP) in conjunction withstudy 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. •Maintain and monitor the conduct of existing trials, including managing patientenrollments/randomizations and opening, closing, or suspending studies, as required, accordingto established departmental SOPs and study DMPs.•Monitor the quality of submitted research data through all EDC systems to evaluate timeliness ofinstitutional data submissions and the completeness and internal consistency of data. Determineif modifications or enhancements to data validations are required to prevent and correct dataerrors and omissions.•In collaboration with the study team and in line with COG policies and procedures, actively resolvedata-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 versussubmitted research data in EDC systems.•Attend study team meetings, regularly provide study progress updates, and address any studyrelated issues.

• Coordinator for stage 2 and 3 clinical trials for investigative pharmaceutical products • Prepared subject charts for FDA audit• Obtained subject's written informed consent per SOP and IRB guidelines• Conducted study procedures and assessments per protocol • Served as liaison between principal investigator, sub-investigator, sponsor, subjects, etc.• Completed case report forms and respond to data queries in a timely manner• Performed accountability of investigational product

• Coordinator for stage 2 and 3 clinical trials for investigative pharmaceutical products • Prepared subject charts for FDA audit• Obtained subject's written informed consent per SOP and IRB guidelines• Conducted study procedures and assessments per protocol • Served as liaison between principal investigator, sub-investigator, sponsor, subjects, etc.• Completed case report forms and respond to data queries in a timely manner• Performed accountability of investigational product

• Facilitated a safe environment for university residents to live• Conducted community walks to ensure safety• Responded to phone calls for assistance• Planned and advertised programs for the community• Worked as part of a staff to meet objectives