Job Description
Who is Saint Louis University? Founded in 1818, Saint Louis University is one of the nation's oldest and most prestigious Catholic universities. SLU, which also has a campus in Madrid, Spain, is recognized for world-class academics, life-changing research, compassionate health care, and a strong commitment to faith and service.
JOB SUMMARY The Clinical Research Nurse - Pediatrics is responsible to carry out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. The Clinical Research Nurse is a primary resource for study protocol conduct acting as a liaison between the SLU SOM, clinical partners (e.g., SSM Health), the Principal Investigator, Institutional Review Board (IRB), and sponsors to ensure good clinical practice standards (GCP) throughout the life cycle of the study. This position may participate in the day-to-day operations of clinical research studies conducted at SLU, and perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. Additionally, this position may oversee the work of junior staff and train or mentor others in clinical research tasks, as well as providing and documenting professional nursing care for research participants.
PRIMARY JOB RESPONSIBILITIES - Assists with or contributes to the development of funding proposals; uses scientific proposals from the PI, develops research protocols; demonstrates a basic understanding of the elements of research study designs; independently conducts literature searches and reviews; contributes to the development of scientific publications or presentations and serves as an author on poster presentations or publications
- Collects appropriate information to determine whether the study teams participation in a specific trial is feasible; shares feasibility documentation with the Principal Investigator and Department Chair or Vice Chair of Research as appropriate; ensures that studies are conducted in compliance with institutional requirements and other policies; follows, and implements, protocol specific systems and documents including process flows; prepares for, coordinates, and actively participates in site visits; communicates effectively with sponsors and/or contract research organizations (CROs); for studies with complex supplies or equipment, ensures that there are ample supplies, and that equipment is in good working order; may assist with forecasting staffing needs; uses clinical trials management system (CTMS) and system reports to manage research participants activities and charge routing; prepares studies for closeout and document storage
- Recruits, screens, assigns, monitors, maintains, and terminates study subjects
- Communicates with outside vendors to obtain the services required to meet the need of the research protocol
- Schedules, performs, and/or supervises required study tests
- Responsible for the operational aspects of the clinical research implementation; coordinates a protocol from its inception to completion and problem solve difficulties during its life cycle
- Maintains participant-level documentation for all studies, including those that are complex in nature, require access to the EHR or require SLUCare/SSM charge routing; screens participants for complex studies (e.g., procedural, and interventional studies)
- Conducts and plans for visits for complex studies (e.g., procedural, and interventional studies)
- Maintains study-level documentation for all studies, including those that require charge routing to SLUCare or SSM; may maintain study level documentation for international studies and develop resources and tools for management of international studies, and/or coordinate with other entities or offices
- Applies appropriately in study documentation, protocol submissions, and standard operating procedures (SOPs); develops or helps develop SOPs; leads meetings that are multidisciplinary, including those with complex objectives
- Monitors and initiates corrective action to maintain the environment of care, including equipment and material resources; participates in the identification of clinical or operational performance improvement opportunities and in performance improvement activities
- Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties
- Identifies all adverse events (AEs) and determines whether or not they are reportable; collaborates with the PI to determine AE attributes, including relatedness to study; conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require clinical research orders in EHR; develops consent plans and documents for participants in a variety of studies; develops and submits documentation and information for Institutional Review Board (IRB) review; communicates with the IRB staff and reviewers and handles issues appropriately; prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies; responsible for adherence to clinical research policies to ensure ethical conduct and protect vulnerable populations; communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation
- Enters and collects data and develops data entry or collection SOPs or tools; may provide oversight or training to study team members collecting or entering data; ensures accuracy and completeness of data for all studies; recognizes and reports security of physical and electronic data vulnerabilities; may develop or review research data security plans (RDSPs) for multiple study protocols; maps a protocols data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.)
- Performs other duties as assigned
KNOWLEDGE, SKILLS & ABILITIES - Knowledge in regulatory and institutional policies and processes
- Proficiency in electronic medical records and relevant computer software
- Strong verbal and warren communication skills, attention to detail is essential
- Ability to use computing software and web-based applications (e.g., Microsoft Office products and the electronic medical record)
- Ability to work in a team environment to facilitate the integrity of the study and its timely completion
- Ability to travel to off-site locations
MINIMUM QUALIFICATIONS - RN with current registration to practice nursing in St. Louis
- Five to seven years of relevant nursing experience, two years of which must be clinical research/research nurse coordinator experience
- Current Basic Life Support (BLS) Certification
Function Clinical Research
Scheduled Weekly Hours:
40
Saint Louis University is an equal opportunity/affirmative action employer. All qualified candidates will receive consideration for the position applied for without regard to race, color, religion, sex, age, national origin, disability, marital status, sexual orientation, military/veteran status, gender identity, or other non-merit factors. If accommodations are needed for completing the application and/or with the interviewing process, please contact Human Resources at 314-977-5847.
Job Tags
Full time, Contract work,