Clinical Research Associate II

This is a 95% grant funded position and contingent upon future funding.

Job 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.

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.