Clinical Research Associate II

Job Responsibilities

• Data Abstraction, Data Curation, and Data Management: Performs data abstraction and data curation from health records, including review, interpretation, and organization of clinical information, and prepares curated data for entry into research databases using standardized formats guided by clearly defined core concepts. Ensures that study data are accurate, complete, and entered in a timely manner. Develops, maintains, and monitors case report forms and research databases to support assigned studies.
• Protocol Compliance and Study Support: Ensures compliance with protocol-specific interventions, evaluations, and data collection requirements for assigned studies. Collaborates with research teams to address data-related questions, resolve discrepancies, and support ongoing study activities.
• Reporting and Participant Communication: Provides data summaries, reports, and other research-related information to collaborating research teams. Prepares participant evaluation reports and other study-related communications for sharing with research participants, as appropriate.
• Quality Assurance and Data Integrity: Ensures that data abstraction, data curation, and data management activities comply with departmental standards for accuracy, completeness, consistency, and timeliness. Participates in quality assurance activities, identifies data discrepancies, and facilitates their resolution to ensure data integrity across study datasets.
• Process Improvement and Operational Support: Contributes to the development, review, and revision of standard operating procedures and work processes. Supports adaptations required by changes in electronic health records, research databases, regulatory requirements, and departmental priorities.
• Act as site study coordinator conducting informed consent process as designated, and assisting with protocol submissions (internally sponsored and/or externally sponsored) for review by federal or institutional committees (e.g. CTSRC and IRB) as applicable.
• Develop, maintain, monitor, and/or share assigned/relevant documentation (e.g., investigator files, case report forms, study data).
• Perform data abstraction, collection, and entry to support clinical research.
• Prepare submission for all reportable events (e.g., adverse events, protocol variances, violations).
• Prepare detailed data reports as required.
• (As applicable) Provide patient care, education, and management (e.g., routine test conduct; assistance in clinical procedures; medication instruction, monitoring, and documentation; patient care coordination; education on protocol activities).
• Perform other duties as assigned to meet the goals and objectives of the department and institution.
• Maintains regular and predictable attendance.

Requirements

• Minimum Education and/or Training: Bachelor's degree in relevant area required. Master's degree preferred.
• Minimum Experience: Minimum Requirement: 2+ years of experience in carrying out research preferably in healthcare settings. Experience Exception: Master's degree and some experience preferred. Experience managing cross-functional communication, including liaison between site and study teams. Some experience with documentation and tracking systems/processes. Proven performance in earlier role. Medical experience (Physician or RN) preferred.