Job Description

Operates independently with limited supervision. Acts as Project Manager for institutional as well as St. Jude sponsored, multi-center trials, including regulatory, financial, and administrative aspects of the study. Acts as site Study Coordinator for complex, large multi-site and/or multidisciplinary clinical trials. Assists in the development of and ongoing review of departmental/divisional standard operating procedures. Serves as a precepter/mentor to new clinical research staff. 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.

Job Responsibilities:

List any requirements unique to this position in this department.

• 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:

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• Bachelor's degree in relevant area required.
• Master's degree preferred.

Minimum Experience:

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• 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.

Licensure, Registration and/or Certification Required by Law:

List any licensure or certification REQUIRED and/or PREFERRED by federal or state law to do the job.

• None

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

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• None

Special Skills, Knowledge and Abilities:

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• Ability to look at data more critically and draw meaningful conclusions. Conducts root-cause analysis as needed.
• Quickly rebounds from setbacks, including creating viable plans to move forward.
• Helps others understand the need for change and adapt to it.
• Effectively relays understanding of diverse perspectives.
• Can handle communication upwards and downwards as needed.
• Presents information in a clear, well thought out way and tailored to the audience.
• Shows support for the new direction even when the details have not been finalized.
• Spots early indications of underperformance and takes corrective actions. Celebrates successes.
• Works with partners inside his/her function to find the best solutions that align with functional priorities. Is easy to work with to find solutions.
• Ensures adherence to timelines and GCP guidelines during the conduct of protocol implementation and data collection.
• Leverages knowledge of study and site considerations to provide ongoing direction for assigned studies within own area (research management/operations).
• Understands study interdependencies, and consistently communicates with critical stakeholders to drive execution, escalating as needed.

Physical Demands and Working Conditions:

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• 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.

Compensation

In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $78,000 - $139,360 per year for the role of Sr Clinical Research Associate.

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Diversity, Equity and Inclusion

St. Jude Children’s Research Hospital has a diverse, global patient population and workforce, built on the principles of diversity, equity and inclusion. Our founder Danny Thomas envisioned a hospital that would treat children of the world—regardless of race, religion or a family’s ability to pay.  Learn more about our history and commitment .

Today, we continue the mission to advance cures and means of prevention for pediatric catastrophic diseases through research and treatment. As we accelerate this progress globally, we believe our legacy of diversity, equity and inclusion is foundational to success. With the commitment of leaders at all levels of the organization, we strive to ensure the St. Jude culture, leadership approaches and talent processes are equitable and culturally responsive. View our  Diversity, Equity and Inclusion Report to learn about the hospital’s roots in diversity, equity and inclusion, where we are today and our aspirations for an even better future.

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