Clinical Research Associate I

at  St Jude Childrens Research Hospital

Operates under general supervision. Performs data abstraction, collection, and entry to support clinical research. Prepares submission for all reportable events. Develops, maintains, and/or monitors case report forms. Ensures compliance with prescribed interventions and evaluations of the assigned protocol(s). Provides data to the collaborating research organization or study sponsor. Prepares data reports.

MINIMUM EDUCATION AND/OR TRAINING:

Bachelor’s degree in relevant area required.

MINIMUM EXPERIENCE:

Minimum Requirement: Prior industry experience preferred.

SPECIAL SKILLS, KNOWLEDGE AND ABILITIES:

• 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.
• Seeks clarifications to understand what is being said.
• Is able to clearly summarize information learnt to confirm understanding.
• Writes in a clear and concise manner and speaks succinctly and confidently.
• Plans in advance, organizes own work, and executes high-quality work on time. Shows initiative to take on more responsibilities/work.
• Embraces goals and demonstrates a sense of urgency in achieving them.
• Holds self to high standards and keeps pushing to meet them.
• Supports clinical study and site management by performing basic tasks (operations/study management) under supervision.
• Exhibits understanding of key concepts related to clinical studies (e.g., baseline determinants of new study selection process, risk assessments).

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to stand; walk; sit; kneel, use hands to finger, handle, or feel; and talk or hear.
• The employee must occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, depth perception and the ability to adjust focus.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The noise level in the work environment is usually quiet.
• An essential function of the job is to be able to comply with all applicable federal, state and local safety and health regulations that would apply to this job.
• The employee must move about the work space to access work surface and shelves, cabinets, drawers, and equipment that are at, below or above the work surface.
• Nothing in this job description limits management’s right to assign or reassign duties and responsibilities to this job at any time as business needs dictate. This job description reflects management’s assignment of essential functions; it does not proscribe or restrict the tasks that may be assigned. The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor is it intended to be an all-inclusive list of the skills and abilities required to do the job.

• Perform data abstraction, collection, and entry to support clinical research.
• Assist with submission for all reportable events (e.g., adverse events, protocol variations).
• Maintain/enter data as required for case report forms.
• Ensure compliance with prescribed interventions and evaluations of the assigned protocol(s).
• Provide data to the collaborating research organization (CRO) or study sponsor, and prepare data reports as directed.
• (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.