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.
The Clinical Research Coordinator II (CRC2) will work closely with the Cognition Core Leader and other lab members and will be responsible for project management, vendor management, rater training and tracking, quality control and data verification processes, and ensuring that the Cognition Core follows ICH/GCP standards and additional regulatory requirements from protocol concept through study reporting. Ideally, the CRC2 will have experience with FDA regulated clinical trials and experience with cognitive and clinical assessment measures. DIAN is a global study with sites in EU, Asia, Australia, and North and South America. The position will involve maintaining frequent contact with raters and site coordinators at all DIAN sites as well as with project managers and other representatives from multiple vendors.
PRIMARY DUTIES AND RESPONSIBILITIES:
Quality Control: One of the primary functions of the DIAN Cog Core is to perform quality control reviews of cognitive assessments and verification that these reviews were completed correctly. Because DIAN is a global study, we work with vendors with native language expert clinicians.
The CRC2 will maintain frequent contact with personnel from vendors including project managers, native language experts, and other vendor personnel.
Tracks QC processes with vendors and other core personnel to ensure timely completion. Fields scoring and administration questions from raters and QC reviewers.
Works with Cog Core staff to ensure that QC processes are completed correctly and in accordance with Standard Operating Procedures (SOPs).
Assists with preparation of quality control reviews of study-wide data and assists with reporting updates at quarterly study-wide meetings.
Maintains documentation and materials for Cog Core: Works with Cog Core staff to prepare and maintain Cog Core documentation. Maintains cognitive assessment battery materials and equipment and works with Clinical Core to ensure that materials are up to date and versioned appropriately for all DIAN sites globally. Works with vendors to manage eCOA assessments and equipment. Works with vendors to acquire and update translations for each language used in DIAN studies.
Assists with preparation and updates to SOPs, work instructions, procedures manuals and other documents for the Cog Core.
Reviews federal regulations to ensure compliance (e.g. ICH-GCP).
Assists with responses to external and internal audits to ensure compliance with ICH-GCP and 21 CFR Part 11 compliance.
Rater Management and Training: The CRC2 will assist Cog Core personnel with designing and maintaining a web-based rater training platform provided by a vendor. CRC2 will maintain regular contact with site raters and coordinators for all aspects of cognitive assessments for the DIAN studies.
Assists with regular updates to training content, including incorporating translations of content.
Works with Cog Core personnel to schedules and review practice administrations of cognitive measures.
Tracks all rater certification and manages notification system for certification expiration.
Triages questions from site raters and coordinators regarding Cog Core protocols and escalates as necessary to Cog Core leaders and staff.
Assists with scheduling training webinars for raters and site coordinators.
Works closely with Cog Core leaders and Clinical Core personnel to facilitate critical study communications with raters and site coordinators.
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.
Minimum of 2 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.
Good understanding of the operational execution of clinical protocols.
Document development skills (e.g. formatting) in MS Word, Powerpoint, and Adobe Acrobat.
Basic business writing skills for protocols, amendments, memorandums, 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, and investigators.
Applicant Special Instructions:
Must be able to travel as necessary (i.e. investigator meetings, seminars or vendor 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.