Clinical Data Entry Coordinator

Overview

Hybrid Position - Office & Work from Home

Currently seeking a Data Entry Coordinator (DEC I / DEC II) to support our Business Operations Team. The DEC I/DEC II shall have primary responsibility to enter accurate information in applications such as the Investigator Database, Clinical Trial Management System (CTMS), and AGS
360 or equivalent aggregate spend system. The DEC I/ DEC II shall monitor the Clinical Systems service mailboxes and file, retrieve, distribute, and review according to quality standards, and resolve quality issues with clinical operations personnel. In addition to these responsibilities, the DEC II will provide support for ad-hoc requests and assist with special projects/assignments.

Required to perform the functions and duties described below:

• Responsible for entering accurate information to the following applications:
• Create, maintain, and update both investigator and site data to the investigator database based on new or updated Investigator Generic Screens, Investigator CVs or / and any related documents from internal and external sources.
• Create, maintain, and update investigator, site, and staff data in CTMS based on the Regulatory documents (e.g. FDA 1572) and/or from a pre-designed template.
• Update CTMS trial information related to investigators in the BIPI Investigator Database.
• Create, update and QC spend data and site data in AGS
  360 based on the vendor submitted trial spend data.
• Monitor Clinical Systems service mailboxes- 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
• File, retrieve and distribute investigator and site related documents based on the business process.
• 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.
• Ability to perform complex web-based research.
• Create and manage Excel spreadsheets / trackers.

In addition to the above, the DEC II would be required to perform the functions and duties described below:

• Provide support for ad-hoc requests from business partners.
• Create and manage Excel spreadsheets / trackers. Must be proficient in Excel (calculations and functions).
• Assist with special projects / assignments as required (e.g. run reports and provide data analysis).
• Assist Open Payments/Sunshine Act support:
• Prepare data for Open Payments (Sunshine Act) for upload into AGS
  360 (e.g. CTSU drug data).
• Assist with Vendors’ spend data and inquires, internal Clinical Trial Leader/Clinical Trial Manager inquires on spend data.
• Reconcile data and identify discrepancies to ensure data quality.

4-year degree or relevant experience

The successful candidate will:

• Possess highly proficient computer skills, with hands-on working experience in multiple electronic platforms such as but not limited to:
  Microsoft Office 365 Suite, MS Teams, SharePoint, Skype for Business, Adobe Acrobat Professional.
• Maintain expertise of currently assigned BI SOPs, BI WIs and where applicable;
  Study Management & Conduct, Site Monitoring, Regulatory Document Group, or Investigational Product Clearance departmental practices and systems.
• Understand and maintain current knowledge of ICH, GCPs, and applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets.

Contractor/ISP will comply with the following Key Performance Indicators (KPIs).

• Time Recorder Compliance

Office & Work from Home

What's your highest level of education completed?

How many years of work experience do you have with Microsoft Excel?*

How many years of work experience do you have with Clinical Trial Management System (CTMS)?*

Are you able to participate in a hybrid position that includes both in-person and remote work?*

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