Data Coordinator
Care Access · United States · remote
About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
Data Coordinators play an important role in clinical research by helping ensure study data is accurate, complete, and available when needed. As part of a centralized data coordination team, this role helps protect data integrity, and support Care Access’ mission to make clinical trials more accessible to participants everywhere.
Through source data quality control, accurate EDC/CRF transcription, visit-to-entry reconciliation, and proactive query follow-up, Data Coordinators help keep study records reliable and inspection-ready. By catching discrepancies early and helping move issues to resolution, this role contributes to smooth study operations across the Care Access site network.
How You'll Make An Impact
- 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.
The Expertise Required
- 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 q