Description
Job Description
Better at Work. Better at Life.When you work at St. Jude, you’ll join a highly collaborative work culture that inspires you every day to be your best. With opportunities for learning and growth, you can shape a career path that is right for you while also enjoying all the benefits and stability of working for a world-class institution. This includes work-life balance with generous paid time-off and on-campus conveniences that make life a little easier. Join us and you’ll quickly see why St. Jude is consistently ranked by our employees on Glassdoor as a “Best Place to Work.”
The Sr Clinical Research Associate 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. We are seeking a Sr. Clinical Research Associate to join our team. The position will be within the Center for Experimental Neurotherapeutics (CENT), a newer clinical research program at St Jude. The CENT mission is to bring children with catastrophic genetic neurological disorders to St. Jude, study these disorders to better understand their clinical course, and develop/test novel gene-directed therapies. As such, the selected candidate will have a passion for working with patients and families, an interest in working in a dynamic start-up environment, and a team-oriented attitude.
Job Responsibilities
- Support project management (lead/monitor planning and delivery) for institutional as well as St. Jude sponsored, multi-center trials, including regulatory, financial, and administrative aspects of the study.
- Act as site study coordinator for complex, large multi-site and/or multidisciplinary clinical trials.
- Maintain and share essential study documents (e.g., investigator files, case report forms) as required.
- Assist with protocol submissions (internally sponsored and/or externally sponsored) for review by federal or institutional committees (e.g., CPSRMC and IRB) as applicable.
- Assist in the development of ongoing review of departmental/divisional standard operating procedures. and ensure compliance in execution of assigned tasks.
- Oversee quality of data abstraction, collection, and entry to support clinical research of study team members.
- (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: 4+ years of experience in carrying out research preferably in healthcare settings.
- Experience Exception: Master's degree and 2+ years of experience.
- Experience managing cross-functional communication, including liaison between site and study teams.
- Experience with documentation and tracking systems/processes.
- Proven performance in earlier role.