Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status.
This position is full-time and works approximately 40 hours per week.
Department Name/Job Location:
This position is in the Department of Neurology. This position is for the Medical School Campus.
The Clinical Research Coordinator II will support and assist in the operational planning, management and execution of multiple phase II/III global/international trials conducted in accordance with ICH/GCP and local and regional requirements from protocol concept through clinical study report for the DIAN-TU.� The DIAN-TU will be the regulatory sponsor and coordinating center for the DIAN-TU and for major drug trials for the prevention of Alzheimer’s disease.� The DIAN-TU, including the DIAN-TU Trials, is funded through a partnership between Washington University, the Alzheimer’s Association, pharmaceutical partners, the National Institute on Aging, and various other funding sources.� Washington University (DIAN-TU) will serve as the regulatory sponsor and FDA IND holder for the trial(s).�
PRIMARY DUTIES AND RESPONSIBILITIES:
Major responsibility for the supporting and assisting in the operational planning, management and execution of multiple phase II/III global/international trials conducted in accordance with ICH/GCP and local and regional requirements from protocol concept through clinical study report for the DIAN-TU.� Duties include support and assist the Clinical Operations team in the management and operations of the DIAN Trials Unit clinical trials programs including coordination and development of systems and processes to support trial operations and compliance.� Working knowledge of Good Clinical Practices (GCPs); International Conference on Harmonization (ICH); European Community Guidelines, and Food and Drug Administration (FDA) regulations; HHS Policies and Guidelines.
Assist with the development, implementation, and ongoing updates of policies and processes to ensure regulatory compliance during start-up, conduct and closure of clinical research studies including management of the DIAN-TU Trial Master File.�� Processes include management of onboarding and training tracking for all team members; follow-up with DIAN-TU members on pending or missing training records.� Assist with, provide input on, and develop/modify DIAN-TU Standard Operating Procedures (SOPs).
Implement and maintain tracking systems and procedures for these processes, i.e. Trial Master File / Regulatory Master File, and project management systems (ex: SharePoint, Confluence, Jira, etc.).�
Develop, review/enhance and maintain systems and procedures for trial conduct, including electronic databases and operational files.
Proactively identify needs, issues, or areas of improvement and implement processes or solutions to address the needs.� Provides input to problem-solving and implements corrective action plans when necessary.
Bachelor’s degree plus a minimum of two years of clinical research experience; a combination of relevant work and education equaling six years may substitute for this requirement.
ICH-GCP proficiency, CRA experience and practical experience in SOP and CRF development.
Working knowledge of techniques and methodologies of Trial Management File management.
Working knowledge of techniques and methodologies used in developing, coordinating, and managing clinical research projects with working knowledge of database management and spreadsheets.
Good understanding of the operational execution of clinical protocols.
Basic business writing skills for protocols amendments, study summaries, and progress reports.
Experience with various electronic data capture, web-based applications, and storage systems.
Excellent communication skills (both written and oral). Ability to be clear, direct, and tactful when communicating with multiple sites (national and international), departments, staff, CROs, vendors (e.g. Home Health Nurses), and investigators.
Willing to travel as necessary (i.e. investigator meetings, seminars or company meetings, etc).
The hiring range for this position is $48,131 - $60,174 annually.
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. Current employees applying for a new position within the university may be subject to this requirement. The screenings will include a criminal background check and, as applicable for the position, other background checks, drug screen, employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.
Please attach a copy of your most current signed performance evaluation (completed within the last 18 months) to your online account. If you have not received a performance evaluation, you may provide two current signed letters of recommendation (written within the last 18 months), preferably to include one letter from either a current or recent former supervisor. To attach these documents, go to: My Career Tools, Add Attachment, Attachment Type – Performance Reviews or Letters of Recommendation.
Washington University in St. Louis, a medium-sized, independent university, is dedicated to challenging its faculty and students alike to seek new knowledge and greater understanding of an ever-changing, multicultural world. The University offers more than 90 programs and almost 1,500 courses leading to bachelor's, master's and doctoral degrees in a broad spectrum of traditional and interdisciplinary fields, with additional opportunities for minor concentrations and individualized programs. The faculty is composed of scholars, scientists, artists and members of the learned professions. They serve society by teaching; by adding to the store of human art, creativity, understanding, and wisdom; and by providing direct services, such as health care.