Washington University of St. Louis Clinical Research Specialist - Neurology - 46824 in St. Louis, Missouri
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.
Works closely with the Principal Investigator (PI) and other lab members of the Cognitive Technology Research Laboratory (CTRLab) and will be primarily responsible for project management, database management, basic analyses, and execution of the Ambulatory Research in Cognition (ARC) smartphone studies. ARC is used in several ongoing NIH and foundation-funded studies. The position requires familiarity with electronic data capture systems, general database management, and at least basic data analysis skills. Experience with information technology and smartphone app development is preferable. Because ARC is used in the Dominantly Inherited Alzheimer Network (DIAN) studies that include Phase 2/3 clinical trials, there will be a strong emphasis on ensuring that ARC follows ICH/GCP standards and additional regulatory requirements from protocol concept through study report. The most critical aspects of the position include project management of ARC app development and assisting PI, CTRLab members and collaborators with study implementation. Facilitating meetings with vendors, database management, rapid analysis and monitoring of incoming data, scheduling, and communicating with ADRC and DIAN site coordinators, DIAN site raters and Home Health Nurses (HHNs).
PRIMARY DUTIES AND RESPONSIBILITIES:
- Manages databases, runs basic data processing pipelines, monitors incoming study data, and performs basic analyses of study data for ARC smartphone assessments in the DIAN and HASD studies.
- Manage databases: may include REDCap and vendor-customized relational database software.
- Manages a quality system to ensure compliance and to provide timely updates of data quality.
- Performs at least basic statistical analyses of study data to ensure participant adherence and to monitor technical issues as they arise.
- Performs quality control reviews of study data and provides analysis and updates at quarterly study-wide meetings.
- Coordinates all phases of study/protocol for all ARC studies; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes decisions regarding when to notify leadership of issues, and/or to make and/or recommend adjustment of the protocol; resolves IRB/protocol management issues and recommends corrective action as appropriate; serves as liaison with performance site.
- Prepares and updates study Standard Operating Procedures (SOPs), work instructions, and other manuals specific to Ambulatory Research in Cognition (ARC) studies.
- Reviews federal regulations to ensure compliance (e.g. ICH-GCP).
- Facilitates communication between internal departments and site coordinators, site raters, and Home Health Nurses (HHNs) at multiple international sites for the DIAN studies.
- Ensures raters and sites have adequate study inventory and coordinates shipping and delivery of materials as needed.
- Assists with tracking and scheduling of rater training specific to ARC study.
- Provides basic technical support to raters and coordinators for application and device setup for participants and coordination of study device returns.
- Acts as project manager for any changes or updates to the ARC app, including validation of new tests, quality assurance app testing, and managing translation and cultural adaptation of ARC content.
- Performs other duties incidental to the work described herein.
Bachelor of Science degree plus 4 years of clinical or research experience with at least 1 year of lead or supervisory experience included; 8 years of relevant education and work experience may substitute for this requirement.
- Minimum of 5 years of regulated clinical trial (phase II/III) experience is essential.
- 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.
- Working knowledge of database management.
- Willing to ask for clarification or track down additional information independently.
- Ability to establish workflows that comply with regulatory requirements.
- At least a basic understanding of statistical analyses.
- Experience working in culturally diverse environments is highly preferred. Candidates must be committed to the School’s goal of advancing inclusive excellence and be prepared to explain how they have been and/or will be involved in advancing this goal within WUSM.
- Experience with R, Python, or other data analysis software a plus.
- Good understanding of the operational execution of clinical protocols.
- Document development skills (e.g. formatting) in MS Word and Adobe Acrobat for protocol, procedure manual, rater script and other document development.
- 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, software development teams), and investigators.
The hiring range for this position is $62,067 - $79,144 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.
This position is eligible for full-time benefits. Please click the following link to view a summary of benefits: https://wustl.box.com/s/8wkhs25yssf0775x9d6nd6vqa7obpth7
Applicant Special Instructions
Able to travel as necessary (i.e. investigator meetings, seminars or vendor meetings, etc.).
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.
Job Title: Clinical Research Specialist - Neurology - 46824
Job ID: 46824
Location: Medical School
Full/Part Time: Full-Time