Data Coordinator

• Site-Level Quality Control:  
  • Review source data collected during clinic visits and work with clinical staff to clarify or resolve discrepancies before information is entered into Sponsor EDC/CRF systems. Responsibilities include: 
    • Reviewing source records for completeness, internal consistency, and required good documentation practices. 
    • Identifying missing data, incomplete fields, missing signatures, or other potential documentation issues. 
    • Reviewing source records for consistency with protocol requirements and study workflows. 
    • Documenting quality control activities in the approved Care Access system and tracking items through to resolution. 
• Data Reconciliation:  
  • Reconcile study data against supporting documentation to make sure required source records are available, complete, and aligned with study expectations. Responsibilities include: 
    • Confirming availability of required source materials, including lab reports, ECGs, imaging reports, and other visit-related records. 
    • Reconciling visit documentation against required study data points and expected source records. 
    • Maintaining and reconciling adverse event information, informed consent logs, protocol deviation logs, and other study tracking tools. 
    • Identifying missing or inconsistent documentation and tracking items through to completion or resolution. 
• EDC/CRF Data Entry:  
  • Enter study data into Sponsor EDC/CRF systems accurately and on time, using source documentation and study guidance to support reliable trial records. Responsibilities include: 
    • Entering clinical research data in accordance with study requirements, Sponsor expectations, and applicable completion guidelines. 
    • Completing data entry within required study timelines and operational expectations. 
    • Verifying entered data against applicable source documentation before submission or completion. 
    • Applying study-specific EDC/CRF instructions consistently across assigned studies and visits. 
• Query Management:  
  • Manage EDC queries and monitor follow-up items by reviewing, routing, responding, and escalating items as needed to keep data issues moving toward closure. Responsibilities include: 
    • Reviewing EDC queries generated by Sponsors, CROs, monitors, and EDC systems. 
    • Resolving queries directly when responses are supported by existing source documentation. 
    • Routing queries that require source clarification, clinical interpretation, investigator assessment, or input from additional site team members. 
    • Entering approved query responses into the EDC and monitoring open or ageing queries through resolution. 
    • Following up with site personnel when additional input is required and escalating unresolved queries in a timely manner. 
    • Reviewing monitor follow-up letter items and coordinating with site staff, where required, to support timely resolution. 
    • Reporting monitor follow-up items as quality issues in the Care Access QMS, as applicable. 
• Study and Site Coordination:  
  • Work with study teams and site personnel to keep data workflows organized, address open items, and maintain alignment with protocol and Sponsor expectations. Responsibilities include: 
    • Maintaining awareness of assigned study protocols, study-specific requirements, and data entry expectations. 
    • Prioritizing workload based on participant visits, Sponsor timelines, monitoring visits, and database milestones. 
    • Communicating with CRCs, PIs, and site network leadership regarding outstanding data requirements and documentation needs. 
    • Participating in study-specific meetings and trainings, as required, to support successful study execution. 
• Other Responsibilities:
  • Support additional data quality, reporting, documentation, and process improvement work as assigned. 
  • Maintain study trackers, data logs, dashboards, and other tools used to monitor progress, data completeness, and open action items. 
  • Collaborate with cross-functional partners during study start-up, maintenance, monitoring, closeout, and audit or inspection readiness activities, as applicable. 

• Strong attention to detail and ability to review clinical research documentation for completeness, consistency, and data quality. 
• Working knowledge of clinical trial data workflows, source documentation, EDC/CRF systems, and query management processes. 
• Ability to interpret and follow study protocols, completion guidelines, standard operating procedures, work instructions, and study-specific requirements. 
• Effective organizational and time management skills, including the ability to prioritize work across multiple studies, visits, deadlines, and competing data needs. 
• Clear written and verbal communication skills, including the ability to follow up on open items and work effectively with site teams, study teams, monitors, Sponsors, and cross-functional partners. 
• Ability to spot data discrepancies, documentation gaps, and recurring quality issues, and raise or help resolve them appropriately. 
• Comfort working independently in a remote setting while staying accurate, productive, and responsive. 
• Proficiency with common office and productivity tools, including spreadsheets, shared trackers, email, collaboration platforms, and study related systems. 
• Commitment to confidentiality, appropriate handling of clinical research information, and adherence to applicable quality and compliance expectations. 

Certifications/Licenses, Education, and Experience

• Minimum Education:
  • Minimum high school diploma or GED required; associate degree or bachelor’s degree in life sciences, healthcare, clinical research, data management, or a related field preferred. 
• Minimum Experience:
  • 2+ years experience in clinical research, clinical trial support, healthcare operations, data coordination, data entry, quality control, or a related role preferred. 
  • Experience reviewing, entering, reconciling, or maintaining structured data using electronic systems, spreadsheets, trackers, or databases. 
  • Experience working with confidential or regulated information and an understanding of the importance of accuracy, documentation quality, and proper information handling. 
  • Familiarity with electronic data capture systems, case report forms, clinical source documentation, query resolution preferred. 
  • Experience working with internal teams, site staff, monitors, Sponsors, CROs, or other cross-functional partners to resolve documentation, data, or operational follow-up items preferred. 
  • GCP, clinical research, healthcare, or data management experience preferred, but not essential.