Data Coordinator (I / II) is required to perform the functions and duties described below:
Create, update investigator data and site data to the investigator database based on new or updated Generic Screen, Site Profile Form or/and any related documents from internal and external sources.
Create, update investigator data and site and staff data in CTMS based on the Reg. documents (e.g. FDA 1572).
Update accurate investigator site information to Clinical Trial Management System (CTMS) from the pre-designed template.
Update CTMS trial information related to investigators in the Company investigator Database.
Create, update spends data and site data in ClearingHouse based on the vendor submitted trial spend data.
Monitor Clinical Operations Support (COS) service mailbox- example tasks as follow: PI/site inquiries, External and internal referrals, internal request regarding PIs and sites, vetting requests, CTMS Study site set up or update requests, Vendors’ spend data and inquiries, internal TCMs/CMLs inquire on spend data
File, retrieve and distribute investigator and site related documents based on the business process.
Provide support for ad-hoc requests from the supporting areas.
Review the CTMS request and investigator information forms according to established quality standards for completeness and accuracy.
Follow the business process to complete the CTMS study site template request properly.
Resolve quality issues with clinical personnel by requesting corrections and if needed clarification in an expedited manner.
Create and manage Excel spreadsheets/trackers. Must be proficient in proficient in Excel spreadsheets.
Assist with special projects/assignments as required. (e.g. run reports and provide data analysis)
Assist Open Payments/SunshineAct support:
Prepare data for Open Payments (Sunshine Act) for upload into SupplierXchange or entry into ClearingHouse (e.g. CTSU drug data)
Provide support to external vendors by helping troubleshoot system issues
Reconcile data, identify discrepancies to ensure data quality
Provide assistance with quality checking
Assist Ethics and Compliance in resolving data issues in Clearview (e.g. Missing site information)
** Data coordinator II: additional tasks.
Education: Bachelor Degree or equivalent
Year of experience: 1 – 3 years (Data coordinator I)
Year of experience: 4 years + (Data Coordinator II)