Operates under general supervision. Performs activities consistent with those of a Study Coordinator role such as maintenance of protocol portfolio(s), informed consent(s), and preparation/submission of complex study documents. 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 complex data reports. Serves as a mentor and preceptor to staff. This is a hybrid position with some evenings/weekends involved. Job Responsibilities: Acts as site Study Coordinator by maintaining essential study documents (Investigator File) for assigned protocols, conducting informed consent process as designated by principal investigator (PI), and assisting PI with protocol submissions (internally sponsored and/or externally sponsored) for review by federal or institutional committees (e.g. CTSRC and IRB) as applicable. Serves as preceptor/mentor to new clinical research staff. Performs data abstraction, collection, and entry to support clinical research. Prepares submission for all reportable events (e.g., adverse events, protocol variances, violations, 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 detailed and high complexity data reports. Maintains appropriate professional competencies; completes appropriate training on the protection of human subjects during the first 6 months of employment. Performs other related duties as directed to meet the goals and objectives of the department and the institution. Minimum Education and/or Training: Bachelor’s degree in a related biomedical/bio-behavioral field required Master’s degree preferred Minimum Experience: Two (2) 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 the 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 No Search Firms St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.