Clinical Research Associate-RN II
About The Position
The Clinical Research Associate-RN II works within the Center for Experimental Neurotherapeutics (CENT), whose mission is to bring children with catastrophic genetic neurological disorders to St. Jude, study the disorders and 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; oversight of compliance with protocol interventions and evaluations; and provision of data and reports to collaborating research organizations or study sponsors. The selected candidate is expected to be passionate about working with patients and families, interested in a dynamic start-up environment, and team-oriented. Depending on the study, responsibilities may also include patient care, education, and management. The position is full-time, with a weekday day shift and 40 scheduled hours per week.
Requirements
- Bachelor's degree in Nursing.
- At least 2 years of experience carrying out research, preferably in healthcare settings; the posting notes an experience exception for candidates with a master's degree and some experience.
- Experience managing cross-functional communication, including liaison between site and study teams.
- Some experience with documentation and tracking systems or processes.
- Proven performance in an earlier role.
- Current Tennessee State Board of Nursing license if the primary residence is Tennessee or a Nurse Licensure Non-Compact state; if the primary residence is in a Nurse Licensure Compact state, a current nursing license in the state of primary residence is required.
- Ability to think critically, draw insights, connect information, and adapt with resilience and flexibility.
- Ability to learn and apply skills in routine tasks, deliver under supervision and guidance, seek information, draw conclusions from available data, and adapt to changing priorities.
- Ability to communicate complex ideas effectively to diverse audiences, convey diverse perspectives, communicate upward and downward, and present information clearly and appropriately for the audience.
- Ability to set high targets, follow through, achieve results, anticipate roadblocks, and find effective solutions with partners.
- Skills with clinical data management processes and tools, including sourcing and compiling data, assisting with data-management tasks, resolving data queries, and ensuring compliance with study data-quality SOPs.
- Knowledge of study operations and oversight, and ability to plan and manage study activities across sites.
- Ability to execute assigned study management and research procedures in compliance with GCP guidelines, with minimal supervision, and apply knowledge of clinical study and site operations.
- Knowledge of regulatory, safety, and/or human-subject-protection considerations related to product development or clinical trial conduct.
Nice To Haves
- Master's degree in Nursing or a related qualification as applicable to the stated degree preference.
- Research experience in healthcare settings.
- A master's degree with some research experience is identified as an experience exception/preferred alternative.
Responsibilities
- Act as a site study coordinator, conduct informed consent as designated, and assist 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, such as adverse events, protocol variances, and violations.
- Prepare detailed data reports as required.
- As applicable, provide patient care, education, and management, including routine tests, assistance with clinical procedures, medication instruction and monitoring, 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
