Data Coordinator

This is a fully remote position, open to applicants in United States.

📋 Description

• Review source data and records to ensure completeness, consistency, adherence to good documentation practices, protocol compliance, and alignment with study workflows.

• Identify any missing data, incomplete fields, absent signatures, and documentation discrepancies.

• Document quality control activities and monitor issues until they are resolved.

• Reconcile study data with relevant documentation, including lab reports, ECGs, imaging reports, and visit-related records.

• Maintain and reconcile information on adverse events, informed consent logs, protocol deviation logs, and study tracking tools.

• Accurately and promptly enter clinical research data into Sponsor EDC/CRF systems.

• Verify the entered data against source documentation and adhere to study-specific EDC/CRF guidelines.

• Review, route, respond to, and escalate EDC queries as necessary.

• Resolve queries backed by source documentation and route those needing clarification, clinical interpretation, investigator assessment, or additional site input.

• Monitor open and aging queries until resolved and follow up with site personnel.

• Review items from monitor follow-up letters and report relevant quality issues in the Care Access QMS.

• Stay informed about assigned protocols, study-specific requirements, and data entry expectations.

• Prioritize tasks based on participant visits, Sponsor timelines, monitoring visits, and database milestones.

• Communicate with CRCs, PIs, site network leadership, study teams, monitors, Sponsors, CROs, and cross-functional partners.

• Participate in study meetings and training sessions.

• Maintain study trackers, data logs, dashboards, and action-item monitoring tools.

• Support activities related to data quality, reporting, documentation, process improvement, study initiation, maintenance, monitoring, closeout, audits, and inspection readiness.

⛳️ Requirements

• A minimum of a high school diploma or GED is required; an associate or bachelor’s degree in life sciences, healthcare, clinical research, data management, or a related field is preferred.

• At least 2 years of experience in clinical research, clinical trial support, healthcare operations, data coordination, data entry, quality control, or a related role is preferred.

• Experience in reviewing, entering, reconciling, or maintaining structured data using electronic systems, spreadsheets, trackers, or databases.

• Familiarity with handling confidential or regulated information and understanding the importance of accuracy, documentation quality, and proper information management.

• Preferred experience with electronic data capture systems, case report forms, clinical source documentation, and query resolution.

• Experience collaborating with internal teams, site staff, monitors, Sponsors, CROs, or other cross-functional partners to resolve documentation, data, or operational follow-up items is preferred.

• GCP, clinical research, healthcare, or data management experience is preferred but not mandatory.

• Strong attention to detail and capability 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.

• Ability to identify data discrepancies, documentation gaps, and recurring quality issues, and escalate or assist in resolving them.

• Capability to work independently in a remote environment while maintaining accuracy, productivity, and responsiveness.

• Proficiency with spreadsheets, shared trackers, email, collaboration platforms, and study-related systems.

• Commitment to confidentiality and adherence to applicable quality and compliance standards.

• Care Access is currently unable to sponsor work visas.

🏝️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays.

• 100% Employer-covered medical, dental, and vision insurance plan options.

• Health Savings Account and Flexible Spending Accounts.

• Bi-weekly HSA employer contribution.

• Company-paid Short-Term Disability and Long-Term Disability insurance.

• 401(k) Retirement Plan with Company Match.

• Travel requirements are less than 10%; occasional planned travel may be necessary.