Research Project Coordinator I
About The Position
The Research Project Coordinator I will coordinate logistics, review requirements, and confirm accuracy for the shipping and collection of materials and supplies for the main study as well as for sub-studies. Assist with Troubleshooting and problem-solving issues with study systems, reports, data queries. Support Research Project Coordinator II-III and Research Project Manager I-III to oversee the management and reporting of data (e.g., creating/testing data reports, assisting with database set-up, validating data). Request and review reports from the Statistics and/or ICT Department(s) to maintain data integrity of the study. Develop and maintain study support tools, reports, and trackers (i.e. manuals, instructional documents). Maintain and manage access to study database and systems for all study personnel. Maintain ongoing communication with sites regarding all study related materials and issues to ensure all materials are up to date. Compile and review documentation required for Good Clinical Practice and/or as required from the study sponsor. Coordinate drug supply and demand with study sponsor and IP manufacturer, packager, distributor to prevent shortages and overages. Perform activities related to major protocol deviations and data transfers. Provide training to PHRI and external study staff. Implement protocol amendments in consultation with the Research Project Coordinator II-III/Research Project Manager I-III/(Associate) Program Manager, Research Operations. Review IP-related information provided on study CRFs. Apply and resolve queries. Provide user access to IP management systems (IVRS/IWRS). Other duties as assigned.
Requirements
- Proficient in Microsoft Office Suite.
- Ability to problem-solve, work independently, adapt to constant change, take initiative, self-motivate, be flexible, and multi-task.
- Excellent communication (written and verbal) and interpersonal skills.
Nice To Haves
- Bachelor’s degree related to Health or Business preferred.
- Familiarity with electronic data capture software and data authoring software such as Framemaker, iDataFax, TrialMaster, or RedCAP.
Responsibilities
- Coordinate logistics, review requirements, and confirm accuracy for the shipping and collection of materials and supplies for the main study as well as for sub-studies.
- Assist with troubleshooting and problem-solving issues with study systems, reports, and data queries.
- Support Research Project Coordinator II-III and Research Project Manager I-III to oversee the management and reporting of data (e.g., creating/testing data reports, assisting with database set-up, validating data).
- Request and review reports from the Statistics and/or ICT Department(s) to maintain data integrity of the study.
- Develop and maintain study support tools, reports, and trackers (i.e. manuals, instructional documents).
- Maintain and manage access to study database and systems for all study personnel.
- Maintain ongoing communication with sites regarding all study related materials and issues to ensure all materials are up to date.
- Compile and review documentation required for Good Clinical Practice and/or as required from the study sponsor.
- Coordinate drug supply and demand with study sponsor and IP manufacturer, packager, distributor to prevent shortages and overages.
- Perform activities related to major protocol deviations and data transfers.
- Provide training to PHRI and external study staff.
- Implement protocol amendments in consultation with the Research Project Coordinator II-III/Research Project Manager I-III/(Associate) Program Manager, Research Operations.
- Review IP-related information provided on study CRFs.
- Apply and resolve queries.
- Provide user access to IP management systems (IVRS/IWRS).
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What This Job Offers
Career Level
Entry Level
