Clinical Research Associate-RN II
About The Position
The Clinical Research Associate-RN II joins the Center for Experimental Neurotherapeutics (CENT), whose 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. The role supports clinical research through data abstraction, collection, and entry; development, maintenance, and monitoring of case report forms; ensuring compliance with prescribed protocol interventions and evaluations; and providing data and reports to collaborating research organizations or study sponsors. The selected candidate should be passionate about working with patients and families, interested in a dynamic start-up environment, and team-oriented. The position may also provide patient care, education, and management as applicable, including routine testing, assistance with clinical procedures, medication instruction and monitoring, care coordination, and education about protocol activities. The role maintains regular and predictable attendance and may perform other duties in support of department and institutional goals.
Requirements
- Bachelor's degree in Nursing.
- At least 2 years of experience carrying out research, preferably in healthcare settings.
- Experience managing cross-functional communication, including liaison work between site and study teams.
- Some experience with documentation and tracking systems or processes.
- Proven performance in an earlier role.
- Current nursing license as specified by the candidate's primary residence: Tennessee license for Tennessee residents or residents of non-compact states; license in the state of primary residence for residents of Nurse Licensure Compact states.
- Ability to think critically, draw insights, and connect information; adapt with resilience and flexibility.
- Ability to learn on the job and apply skills in routine tasks, working under supervision and guidance as needed.
- Ability to understand tasks, seek information, draw conclusions from available data, and adapt to changing priorities.
- Ability to communicate complex ideas clearly to diverse audiences, tailor information to the audience, and communicate effectively across organizational levels.
- Ability to set high targets, follow through, achieve results, anticipate obstacles, and work with partners to find effective solutions.
- Skills in clinical data management processes and tools, including sourcing and compiling data and understanding potential data needs.
- Ability to support data management plans, assist with study-related data processes, resolve data queries based on understanding of data origin and flow, and follow SOPs for data quality.
- Knowledge of study operations and oversight, including the ability to plan and manage study activities across sites.
- Ability to execute assigned study management and research procedures in compliance with GCP guidelines and apply understanding of clinical study and site operations.
- Awareness of safety, ethical, human subject protection, and regulatory considerations related to product development or clinical trial conduct.
Nice To Haves
- Master's degree in Nursing.
- Some experience in addition to a master's degree is preferred.
- Experience carrying out research in healthcare settings.
Responsibilities
- Act as site study coordinator, conducting the informed consent process as designated and assisting with protocol submissions for review by federal or institutional committees, as applicable.
- Develop, maintain, monitor, and/or share assigned or relevant documentation, including investigator files, case report forms, and study data.
- Perform data abstraction, collection, and entry to support clinical research.
- Prepare submissions for reportable events, including adverse events, protocol variances, and violations.
- Prepare detailed data reports as required.
- As applicable, provide patient care, education, and management, including routine testing, assistance in clinical procedures, medication instruction, monitoring and documentation, patient care coordination, and education on protocol activities.
- Perform other duties as assigned to meet department and institutional goals and objectives.
- Maintain regular and predictable attendance.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
