Clinical Research Associate II

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

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.

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.

Nice To Haves

Master's degree preferred.
Master's degree and some experience preferred.
Proven performance in earlier role.

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.