Clinical Research Associate II

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.

Minimum Education and/or Training:

• High School Diploma/GED required.

• Bachelor's degree in relevant area preferred.

Minimum Experience:

• Minimum Requirement: Experience in a research or medical/hospital environment preferred.

Licensure, Registration and/or Certification Required by Law:

• None

Licensure, Registration and/or Certification Required by SJCRH Only:

• None

Special Skills, Knowledge and Abilities:

• Is open to any type of change or new idea presented.

• Shows eagerness to learn from different avenues.

• Addresses needs/ problems in a logical manner, using defined approaches.

• Manages own time well to plan work and meet daily task needs.

• Executes routine tasks under guidance and/ or supervision.

• Shows attention to detail, produces quality work on time.

• Has clear, concise communication in both verbal and written communication.

• Listens to requests, confirms understanding of routine needs, and provides accurate answers.

• Shares information within team as directed.

• Applies basic knowledge of clinical study support processes in delivery of routine tasks (e.g., administrative activities, documentation, inventory maintenance) with guidance.

• Follows standard operating procedures within own area of support.

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.

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-fun