Research Support - Laboratory/Non-Laboratory, Staff/Administrative
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. The position is located at 4488 Forest Park. This position is for the Medical School Campus.
Position assists the DIAN Trials Unit (DIAN-TU) Cognition Core and Clinical Operations team with coordination of all aspects of cognitive assessments for a fast-paced and complex multi-site international clinical trial. The most critical aspects of the position include oversight of monitoring, scheduling, and communications with site raters and Home Health Nurses (HHNs).�
PRIMARY DUTIES AND RESPONSIBILITIES:
Supports and assists 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 supporting the DIAN-TU Clinical Operations team in the management and operations of clinical trials programs of all operational phases of a study/protocol; assists with the development, modification, and/or QC of source documents, forms, manuals, workbooks, questionnaires, and the application of research techniques; assists in the development of instructional procedure manuals for study progress, data collection and coding, etc., as needed for data collection, site use, and trial compliance with federal regulations (e.g. ICH/GCP); ensures missing assessments are identified quickly to ensure completion of read out, i.e. ECGs; reviews federal regulations to ensure compliance (e.g. ICH-GCP).� 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.�
Serve as DIAN-TU Medical Support Specialist for DIAN-TU trials.� Primarily responsible for supporting and assisting the DIAN-TU Medical Monitoring team in the management and execution of the Medical Monitoring Plan for the DIAN-TU trial(s). Duties include:
Triage incoming emails in the DIAN-TU Medic inbox as well as calls received for the DIAN-TU Medical Monitoring Safety Line; manage and route appropriate safety escalations within established timelines; facilitate required site communicate and any required critical correspondence and supporting documentation; facilitate site and CRA support for medical input and guidance on the following activities: protocol interpretation; verification of inclusion/exclusion; re-screening evaluation; study drug dosing modification or interruptions due to visit window issues or adverse event(s).
Provide initial assessment of urgency of abnormal, clinically significant safety labs and ECGs to identify any follow-up required by the site; ensuring appropriate documentation is provided when/if needed; communicate with investigators regarding late or missing safety assessments; present summary and detailed updates on site progress to all relevant team members (both internal and external); participate in the development, implementation, and continual improvement of processes to ensure compliance with protocol guidelines and regulatory requirements throughout research project(s).
Participate in quarterly safety review meetings for identification any new safety issues or trends, abnormalities requiring further review for safety follow-up, or substantial outliers; support any required follow-up on outliers or abnormalities requested by the Medical Team; maintain awareness of drug-specific safety data and information as provided via the DIAN-TU Medical Monitors and DIAN-TU Medical Director.
Routinely participates in internal and external meetings including vendor meetings, team meetings, cross-functional meetings, and site meetings; ensures timely completion of all protocol requirements (assessments, lab testing, procedures, and treatments) to include routine review of site and vendor study activities; facilitates communication with sites and vendors to review progress and address issues.�
Routinely reviews clinical data under clinical research protocols.� Prepares training tools (e.g. presentations, webinars) or processes to ensure clear expectations in the working relationships with vendors, i.e. Home Health Nurse Onboarding Process; performs other duties incidental to the work described herein.�
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.
ICH-GCP proficiency, CRA experience and practical experience in SOP and CRF development.
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 required 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.