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.
Planning and participation in meetings (investigators’ meetings, pharma consortium, pharma partners, etc.) in collaboration with all cross-functional team members.
Secondary duties and responsibilities:
Maintains all essential documents related to the project and uploads documents to the appropriate location for maintenance and storage, i.e. central server, SharePoint, etc.
Must be able to maintain confidential documents and redact documents prior to dissemination, when applicable.
Minutes/action item and deadline / due date tracking.
Meeting preparation and planning activities, e.g. agenda development, drafting presentations, etc.
Assist in project quality control and quality assurance activities, as required.
Applicant Special Instructions:
JOB LOCATION/WORKING CONDITIONS: Very busy office environment with frequent moderate/high pressure caused by deadlines. After hours or weekend responsibility due to urgent situations and international duties occurs.
TRAVEL REQUIREMENTS: Able to fly to various meetings at investigator, pharma partner, trial, vendor or regulatory agency sites. Some international travel may be required.
Bachelor’s degree plus a minimum of 2 years of clinical research experience; a combination of relevant work and education equaling 6 years may substitute for this requirement
Bachelor’s degree plus a minimum of 2 years of clinical research experience; a combination of work and education equaling 6 years may substitute.
Experience in an FDA-regulated phase II and III therapeutic intervention trial is strongly preferred.� Global experience is desirable.
Prior coordinating and/or CRA experience is beneficial.
Experience in a high-level administrative position; Scientific or medical background preferred.
Bachelor's degree, RN, or direct clinical trial work experience in industry-regulated environment.
Minimum of 1 year experience in clinical research environment.
Experience in clinical trial start-up, maintenance and close-out. Good comprehension of drug development and clinical trial methodology.
Proficient in ICH/GCP and industry-regulated IND trial requirements, and an ability to assess compliance to these guidelines.
Ability to organize and multi-task is critical.
Must possess superior organizational skills and be self-motivated.
Ability to prioritize work effectively to meet timelines. Must be flexible with the ability to rapidly and efficiently respond to changing priorities.
Willing to travel as necessary (i.e. investigator meetings, seminars or company meetings, etc.)
Strong working knowledge and ability to exercise appropriate judgment to maintain confidentiality and ensure integrity of data and proprietary information.
Must work effectively in a team environment and be flexible to contribute to the needs of the team.
Skillful communication - clear, direct, and tactful communication skills.
Basic business writing skills required for pharma and site communication.
Budget management exposure is a plus.
Good judgment and professionalism are needed in interfacing with staff, CROs, pharma partners, subject matter experts / thought leaders, study coordinators, and investigators.
Proficient in Microsoft Office programs (Word, Excel, PowerPoint, Project, Publisher, Access, and Outlook).
The hiring range for this position is $46,259 - $57,824 annually.
Offers made for this position are contingent upon the successful completion of all required pre-employment screens, including a criminal background check, hair sample drug screen, and verification of required professional licenses, registrations, or certifications.
-Retirement Savings Plan -22 vacation days -8 Paid Holidays -Sick Time -Tuition benefits for employee, spouse and dependent children -Free Metro Link/ Bus pass -Free Life Insurance -Health, Dental, Vision -Health Savings Accounts (HSA) -Long Term Disability Insurance -Flex Spending Plan -Other Benefits
Med School HR website (medschoolhr.wustl.edu)
Internal Applicant Instruction:
This position is grade C10.
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.