Clinical Research Associate II

St. Jude Children's Research Hospital • Memphis, TN

8d

About The Position

We are seeking a Clinical Research Associate I or II to join our team within the Center for Experimental Neurotherapeutics (CENT), a newly established clinical research program at St. Jude. The mission of CENT is to bring children with catastrophic genetic neurological disorders to St. Jude, study these conditions to better understand their clinical progression, and develop and test innovative gene-directed therapies. The selected candidate should have a strong passion for working with patients and families, an interest in contributing to a dynamic start-up environment, and a collaborative, team-oriented mindset. The Clinical Research Associate I or 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. CRA I Job Responsibilities: Assist clinical research study team(s) in general administrative activities under guidance. Maintain sufficient inventory of material, supplies, and equipment for performance of clinical research-related activities. Assist with the dispensation and receipt of study-related information (e.g., test samples, regulatory documents, etc.). Participate in data retrieval, reporting, and preparation of files for various studies. Escalate issues and problems according to set standards and processes. Perform other duties as assigned to meet the goals and objectives of the department and institution. Maintains regular and predictable attendance. CRA II 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.

Requirements

• Bachelor's degree in relevant area required.
• 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.
• 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