Washington University of St. Louis Neurology 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. This position is for the Medical School Campus.
The DIAN-TU is the regulatory sponsor and coordinating center 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 companies, the National Institute on Aging, in addition to various other funding sources. Washington University DIAN-TU will serve as the regulatory sponsor and FDA IND holder for the trial(s).
The Clinical Research Development Coordinator supports and assists in the operational planning, management and execution of multiple phase II/III international trials for the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) conducted in accordance with ICH/GCP and local regional requirements from protocol concept through clinical study report. This position contributes to the development of trial-related scopes of work, costs, timelines, metrics and deliverables.
This position will focus on clinical vendor project management to ensure the completion of the vendor study deliverables, milestones and objectives. The position will be responsible for coordinating the internal team and core members to manage external vendors, and providing support to trial teams.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Support full scope of study conduct (Clinical Operations) in collaboration with Administrative Operations to ensure the trial(s) are implemented and conducted according to the Code of Federal Regulations, Good Clinical Practices, ICH Guidelines, local regulatory requirements and WU SOPs.
- Collaborate with all relevant groups: multiple pharmaceutical partners; Project Arm Leaders; the DIAN-TU Trial Cores: Biomarker, Biostatistics, Clinical, Cognition, Genetics, Imaging; Trial Project Leaders; CRO(s); vendor(s); investigational sites, and subject matter experts to develop and manage clinical project timelines.
- Management and oversight of CROs and clinical vendors including but not limited to: data management (EDC), central lab, central read (MRI, ECG, etc.), clinical cognitive vendors, IVRS/IWR, home health nursing network, clinical supplies packaging, global CRO (project management, monitoring, regulatory affairs), and pharmacovigilance.
- Facilitate and oversee required clinical vendor documents required for all national level regulatory filings for the trial(s).
- Coordinate regular meetings with study team members and cores as appropriate for the project.
- Disseminates clinical project communication to all functional groups/cores as appropriate.
- Contribute to protocol and amendment development and Clinical Operations feasibility assessments.
- Participation in the selection of CRO and all clinical vendors/components (biomarkers, imaging, data management) for assigned trial(s).
- Contribute to implementation of quality oversight measures and processes for all areas of the trial(s). Identification of trial issues or quality issues for escalation and remediation.
- Planning and participation in investigator meeting(s) in collaboration with all cross-functional team members.
- Ensure training of Project Arm Leaders, all clinical trial sites, vendors, and DIAN-TU Cores on the protocol and expectations of the trial(s).
- Provides input to problem-solving and implements corrective action plan when necessary.
- Partners with CRO and/or applicable team for resolution of recruitment and site performance issues.
- Partners with applicable cores and/or CRO/vendor for resolution of corrective actions as a result of QA audit and/or regulatory inspections.
- Escalate issues as appropriate for medical monitoring, safety, and exemptions/deviations, trial-wide GCP compliance at the sponsor, vendor, and site level, etc.
- Manages to and within timeline and prepare project tracking system with current trial(s) status and provide accurate progress reports on assigned trial(s) as requested.
- Maintains all documents related to the project and uploads documents to the appropriate location for maintenance and storage.
- Development of SOPs and working practices relevant to regulatory sponsor oversight.
- Support DIAN-TU Cores with SOP development, work instructions and process improvement.
- Master’s degree in business or healthcare.
- Previous supervisory experience may be helpful.
- Must possess high degree of diplomacy and professionalism in handling confidential information and maintaining productive relationships with CCS personnel, other WUMC personnel, external sponsors and other customers. Independent judgement and decision-making a must in planning and executing programs and supervising/advising others.
- RN, or equivalent extensive direct clinical trial work experience in industry-regulated environment. Experience at a CRO and/or pharmaceutical environment strongly preferred.
- Minimum of 5+ years’ experience in clinical research, project/program, and vendor and management.
- Experience in clinical trial start-up, maintenance and close-out.
- CRA, CRC, or PM experience in protocol development (trial design) and a strong understanding of the operational execution of clinical protocols from a sponsor perspective.
- 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 manage multiple vendors participating in clinical studies. Specifically, computerized cognitive testing and central laboratory vendors.
- Must possess superior organizational and negotiation skills.
- Strong leadership abilities.
- Ability to prioritize work effectively to meet timelines. Must be flexible with the ability to rapidly and effectively 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 and medical writing skills required for pharma and site communication; protocol and amendment writing or review; study summaries; and progress reports.
- Budget Management - ability to develop a trial budget to monitor and control expenditures; provides justification/rationale for budget variances.
- Demonstrates basic presentation skills at Investigator or team meetings.
- Analytical skills - ability to identify trial-related, CRO-related or site-related issues, determines the causes and possible solutions to the problem.
- Responsible for resolving issues with study conduct with appropriate staff and CRO for a clinical trial(s).
- Good judgment, professionalism and independence are needed in interfacing with staff, CROs, pharma partners, subject matter experts / thought leaders, study coordinators, and investigators.
- Technical Competency - displays in-depth knowledge of clinical study procedures and maintains an awareness of environment as it affects clinical trial execution.
- Proficient in Microsoft Office programs (Word, Excel, PowerPoint, Project, Publisher, Access, and Outlook.
- 5+ years of experience in clinical operation, preferably at a pharmaceutical, biotechnology company or CRO.
- Experience managing FDA-regulated phase II and III therapeutic intervention trials is strongly preferred. Global experience is desirable.
- Prior coordinating and/or CRA experience is beneficial.
- Neurology and/or Alzheimer’s disease experience is highly desirable.
The hiring range for this position is $66,934 - $85,342 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
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
Med School HR website (medschoolhr.wustl.edu)
Applicant Special Instructions
Very busy office environment with frequent moderate/high pressure caused by deadlines. After hours and/or weekend responsibility due to urgent situations and international duties. Able to fly to various meetings (domestic and international) at investigator, pharma partner, trial, vendor or regulatory agency sites.
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 Development Coordinator - Neurology - 41529
Job ID: 41529
Location: Medical School
Full/Part Time: Full-Time