The Department of Global Pediatric Medicine (GPM) is a new and growing department looking for professionals who are eager to help implement the mission of taking St. Jude to the world by training the clinical workforce, developing and strengthening health systems and patient-centered initiatives, and advancing knowledge to sustain continuous improvement through research. GPM is seeking a Clinical Research Associate II- NACHO.
The North American Consortium for Histiocytosis (NACHO) was formed in July 2014 by clinicians and scientists from twelve North American institutions dedicated to developing a research infrastructure to effectively implement clinical and translational studies and conduct biological research of histiocytic diseases. While many other initiatives will be developed and executed in the future, one of our aims is to rapidly design and implement high-impact clinical trials. NACHO currently has over 60 member sites, and 4 clinical trials in progress. The NACHO Operations Center is housed at St. Jude Children’s Research Hospital in Memphis, TN.
The NACHO Operations Center is seeking an organized, detail-oriented CRA to manage NACHO studies in the role of Coordinating Center/Sponsor.
The NACHO Clinical Research Associate II is responsible for:
- Manage and coordinate new and ongoing NACHO clinical trials
- Create and implement protocol specific documents
- Educate and train collaborating site staff on study related activities
- Maintain regulatory study files and essential docs
- Manage study team meetings
- Prepare study reports for NACHO committee meetings
- Manage and perform QA of study databases
- Review site monitoring reports for key issues and assist with corrective and preventive action plans
- Contribute to NACHO Operations projects as needed
All candidates must submit a cover letter to be considered for this position.
- Bachelor’s degree in a related biomedical/bio-behavioral field required
- Master’s degree preferred
- Two (2) years of direct experience in clinical biomedical and/or behavioral research required
- Experience with Phase I, II, and III multi-center clinical trials preferred
Skills and Abilities:
- Knowledge of clinical/biomedical research
- Proficiency in Microsoft Word, Excel, PowerPoint, Projects, Teams, and OneDrive
- Good understanding of Electronic Data Capture systems
- Excellent demonstrated verbal and written communication skills
- Ability to work independently and prioritize duties.
- Excellent organizational ability and attention to detail
- Flexibility in schedule to accommodate meetings across different time zones
- General knowledge of Federal Regulations governing Clinical Research, Good Clinical Practice Guidelines, institutional committee review and reporting requirements (IRB and Scientific Committee), and regulatory affairs
- (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