Clinical Research Associate II

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

About The Position

We are seeking a Clinical Research Associate II to join our team. This position will be within the Center for Experimental Neurotherapeutics (CENT), a growing research program at St. Jude. CENT’s mission is to bring children with catastrophic genetic neurological disorders to St. Jude, study these disorders to better understand their clinical course, and develop and test novel gene-directed therapies. As such, the selected candidate should have a passion for working with patients and families, an interest in a dynamic, start-up environment, and a team-oriented attitude.

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.
Understands the task at hand, seeks out information, and draws conclusions from available data to deliver outcomes.
Adapts quickly to changing priorities to perform as needed in his/her role.
Remains calm when faced with changes to (and in) his/her work.
Effectively relays understanding of diverse perspectives.
Can handle communication upwards and downwards as needed.
Presents information in a clear, well thought out way and tailored to the audience.
Shows support for the new direction even when the details have not been finalized.
Spots early indications of underperformance and takes corrective actions.
Celebrates successes.
Works with partners inside his/her function to find the best solutions that align with functional priorities.
Is easy to work with to find solutions.

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.
Contributes to study management and research procedures by consistently executing on assigned tasks in compliance with GCP guidelines, with minimal supervision
Applies understanding of clinical study/site operations to address requirements (e.g., study selection and set-up, clinical monitoring, risk mitigation support).