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.

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.

• 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. Maintains essential study documents (Investigator File) for assigned protocols. Conducts informed consent process as designated by principal investigator (PI). Assists PI with protocol submissions (internally sponsored and/or externally sponsored) for review by federal or institutional committees (e.g. CPSRMC and IRB) as applicable. Assists PI with protocol submissions (internally sponsored and/or externally sponsored) for review by federal or institutional committees (e.g. CTSRC and IRB) as applicable.
• Assists in the development of and ongoing review of departmental/divisional standard operating procedures.
• Serves as a preceptor/mentor to new clinical research staff and may provide guidance and/or supervision to assigned clinical research staff.
• Performs data abstraction, collection, and entry to support clinical research.
• Prepares submission for all reportable events (e.g., adverse events, protocol variations, etc.).
• 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 (CRO) or study sponsor.
• Prepares data reports.
• Maintains appropriate professional competencies completes appropriate training on the protection of human subjects during the first 6 months of employment.

Minimum Education and/or Training:

• Bachelor’s degree in a related biomedical/behavioral field required. Master’s degree preferred.

Minimum Experience:

Four (4) years of direct experience in clinical biomedical and/or behavioral research required.

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:

List any licensure or certification REQUIRED and/or PREFERRED by St. Jude to do the job.

• (LC:SOCRA or ACRP) Certification in clinical research from the Society of Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP) must be obtained within three (3) years of assuming position.

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.

Other Information

St. Jude is an Equal Opportunity Employer

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