Clinical Research Associate II

St. Jude Children's Research Hospital

1d

About The Position

The Clinical Research Associate II is responsible for performing data abstraction, collection, and entry to support clinical research. Develops, maintains, and/or monitors case report forms. Ensures compliance with prescribed interventions and evaluations of the assigned protocol(s). Provides data and reports to the collaborating research organization or study sponsor.

Requirements

• Bachelor's degree in relevant area required.
• Minimum Requirement: 2+ years of experience in carrying out research preferably in healthcare settings.
• 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.

Nice To Haves

• Master's degree preferred.
• Master's degree and some experience preferred.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level