Scheduled Hours
40
Position Summary
This position is a member of a multi-disciplinary research team and performs duties associated with the coordination and implementation 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 and regional requirements from protocol concept through clinical study report. This position contributes to the development of trial-related scopes of work, timelines, metrics and deliverables. This position will ensure the completion of study deliverables, milestones and objectives through management of assigned study conduct including oversight of trial CROs and vendors, coordination of internal team and core members and/or external vendors, and providing support to trial teams
Job Description
Primary Duties & Responsibilities
- Supports 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).
- Responsible for the development of forms, questionnaires and the application of research techniques; assists in writing instructional procedure manuals for study progress, data collection and coding; reviews journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.
- Identifies problems and/or inconsistencies and monitors participant and site progress; proactively identifies needs, issues, and/or areas of improvement as well as provides input to problem solving.
- Implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; resolves protocol management issues and recommends corrective action as appropriate.
- Routinely participates in external meetings to ensure timely completion of all protocol requirements (assessments, lab testing, procedures, and treatments) to include routine review of vendor study activities; facilitates communication with vendors to review progress and address issues.
- Performs other duties incidental to the work described above.
Preferred Qualifications
- Working knowledge of techniques and methodologies used in developing, coordinating and managing clinical research projects with working knowledge of database management, spreadsheet and statistical analysis software.
Required Qualifications
- Bachelor’s degree plus a minimum of three years of clinical research experience with some level of lead or supervisory experience required; Master’s degree or a combination of work and education equaling seve years may substitute for this requirement.
- Basic Life Support certification (Online BLS certifications, those without a skills assessment component are not sufficient to meet the BLS requirements). BLS certification must be obtained within one month of hire date.
Grade
C12
Salary Range
$60,800.00 - $94,200.00 / Annually
The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.
Questions
For frequently asked questions about the application process, please refer to our External Applicant FAQ .
Accommodation
If you are unable to use our online application system and would like an accommodation, please email [email protected] or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request.
Pre-Employment Screening
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an 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.
Benefits Statement
Personal
Up to 22 days of vacation, 10 recognized holidays, and sick time.
Competitive health insurance packages with priority appointments and lower copays/coinsurance.
Want to Live Near Your Work and/or improve your commute? Take advantage of our free Metro transit U-Pass for eligible employees. We also offer a forgivable home loan of up to $12,500 for closing costs and a down payment for homes in eligible neighborhoods.
WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.
Wellness
Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
Family
We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We’ve got you covered.
WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.
For policies, detailed benefits, and eligibility, please visit: https://hr.wustl.edu/benefits/
EEO/AA Statement
Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University’s policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.
Diversity Statement
Washington University is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment – fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.
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