Clinical Research Assistant

Job Title: Clinical Research Data Coordinator

Location: New Haven, CT (100% Onsite)

Schedule: Full-Time | Monday – Friday | 8:30 AM – 4:30 PM

Job Type: 3-Month Contract (Temporary)

Interview Process: Virtual (Microsoft Teams)

Job Summary

We are seeking an experienced Clinical Research Data Coordinator to support active clinical research studies by ensuring timely, accurate, and compliant clinical data management. This is an immediate-start contract opportunity focused on reducing a backlog of clinical study data while maintaining data quality across multiple research projects. The ideal candidate will have hands-on experience with Electronic Data Capture (EDC) systems, clinical trial documentation, and sponsor/CRO data query resolution.

Key Responsibilities

• Enter clinical research data into Electronic Data Capture (EDC) systems from source documents.
• Review clinical source documentation for accuracy, completeness, and protocol compliance.
• Identify, investigate, and resolve data discrepancies or missing information.
• Respond to sponsor and CRO data queries by reviewing documentation and updating records as needed.
• Support reconciliation of delinquent study visits and maintain current clinical research data.
• Collaborate with Clinical Research Coordinators, investigators, and study teams to resolve documentation issues.
• Ensure compliance with Good Clinical Practice (GCP), study protocols, and regulatory requirements.
• Maintain high standards of data integrity, quality, and confidentiality while meeting project timelines.

Required Qualifications

• High School Diploma or GED required.
• Associate's or Bachelor's degree in Life Sciences, Healthcare, or a related field preferred.
• 3–5 years of experience in clinical research data management, clinical data entry, Clinical Research Coordinator (CRC), Clinical Research Assistant (CRA), Clinical Data Coordinator, or similar clinical research roles.
• Experience working with Electronic Data Capture (EDC) systems.
• Experience reviewing clinical source documentation and maintaining accurate research records.
• Ability to independently manage multiple priorities in a fast-paced clinical research environment.
• Strong analytical, organizational, and problem-solving skills.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Experience with Veeva Vault EDC, Medidata Rave, Dosima, or similar EDC platforms.
• Clinical research certifications such as GCP, CCRC, or CCRP.
• Previous experience responding to sponsor or CRO data queries.

Technical Skills

• Electronic Data Capture (EDC) Systems
• Veeva Vault EDC
• Medidata Rave
• Dosima
• Other comparable EDC platforms
• Microsoft Excel
• Microsoft Word
• Microsoft Outlook

Ideal Candidate

• Detail-oriented with excellent data accuracy.
• Experienced in clinical trial documentation and data reconciliation.
• Able to work independently with minimal supervision.
• Strong understanding of GCP guidelines and clinical research processes.
• Comfortable collaborating with cross-functional research teams while meeting strict deadlines.