Clinical Research Operations Associate II

St. Jude Children's Research Hospital
United States, Tennessee, Memphis
262 Danny Thomas Place (Show on map)
Sep 22, 2024
This full-time on-site position is within the Department of Pharmacy and Pharmaceutical Sciences. Provides direction in coordinating the collection and processing of research and clinical specimens (e.g., pharmacokinetics, pharmacogenomics and pharmacodynamics-related samples) for patients involved in clinical research studies in the Center for Translational Pharmacology. Works directly with principal investigators to ensure that all internal and external regulatory agency policies, procedures, practices, and laws are adhered to by all clinical research personnel. Serves as the contact for internal and external communication regarding correct sample collection, shipping, and tracking to ensure that samples are correctly collected, documented, and distributed and that charges are obtained through the shared resource management system. The associate must maintain an excellent working knowledge of all assigned protocols to ensure the validity of the clinical research data, verify patient eligibility, develop, maintain and/or monitor data collection forms, and enter clinical findings into a study-related database. The associate will learn from some of the most knowledgeable clinical researchers in the world as part of the team. Job Responsibilities: Assists with planning, implementation and management of a complex clinical trial portfolio across all aspects of study development, conduct and oversight. Assists with the conduct of clinical trials supported by the Center for Translational Pharmacology. Ensures that all study-involved processes are completed correctly. Performs data abstraction, collection and entry to support clinical research. Develops study-related documents (e.g., protocols, procedure manuals, eligibility checklists) as required. Understands both research and clinical aspects of protocols to determine the number and design of order templates and study calendars. Serves as a primary resource to clinical investigators, research study team members, and the Clinical Informatics orders team in implementing EHR orders. Manages submissions to Financial Services via the shared resource management system Assists with the development of clinical grant applications and clinical trial programs. Supports the development of National Institutes of Health (NIH) grants by generating relevant metrics and reports. Communicates with study teams and external vendors, as required, across operations cycle (e.g., trial qualification, initiation, monitoring, remote monitoring, close-out activities, interim monitoring meetings). Develops, implements, maintains, and evaluates a quality assurance plan for conduct of clinical protocols. Oversees clinical trial-specific database creation. Assists in the development of standard operating procedures (SOPs) related to Quality Assurance Manages multiple studies while interfacing with a variety of departments. Manages operation/project/protocol budgets and resource allocations. Maintains appropriate professional competencies. Performs other related duties as assigned to meet the goals and objectives of the department and the Center for Translational Pharmacology. Minimum Education and/or Training: Bachelor's degree in relevant area required. Minimum Experience: Minimum Requirement: 2+ years of clinical research experience in a complex disease area (i.e. Oncology, Neuroscience, etc.) Prior clinical research monitoring experience preferred. Prior medical writing experience preferred. Prior nursing or experience in a clinical setting preferred. Prior experience managing flow of clinical trial regulatory documents preferred. 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 $70,720 - $126,880 per year for the role of Clinical Research Operations Associate II. Explore our exceptional benefits! 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. 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.