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 supports and coordinates activities in complex clinical research studies; responsible for sponsor Trial Master File (TMF) maintenance and oversight; coordinate with CROâ™s TMF activities and compliance with regulatory compliance standards; may supervise clinical research staff.

The DIAN-TU is the regulatory sponsor and coordinating center for major drug trials for the prevention of Alzheimerâ™s disease. The DIAN-TU, including the DIAN-TU Trials, is funded through a partnership between Washington University, the Alzheimerâ™s Association, pharmaceutical partners, the National Institute on Aging, and various other funding sources. Washington University (DIAN-TU) serves as the regulatory sponsor and FDA IND holder for the trial(s).

Job Description

Primary Duties & Responsibilities

Internal DIAN-TU Activities

• Management and maintenance of clinical study documents in TMF, both paper and electronic and other systems in an audit/inspection ready state.
• Collaborate with internal team members in the identification and management of clinical study documents to be held in the DIAN-TU TMF, including ClinOps/Admin, and DIAN-TU Cores.
• Perform risk based TMF quality checks, monitor trends, and remediate issues throughout trialsâ™ lifecycles to ensure that the TMF is a high-quality deliverable.
• Identify opportunities for continuous process improvements and recommend solutions.
• Contribute to the development of TMF-related SOPs, working practices, forms, and other tools to ensure compliance with applicable regulations and/or records retention policies.
• Ensure compliance with SOPs, Work Instructions, Key Performance Indicators (KPIs), TMF Study Plans/Supporting Guidance, and/or global regulations, as applicable.
• Support TMF operations in audits and/or inspections in conjunction with Quality Assurance and other functions as needed.
• Represent TMF operations at meetings to provide status updates, oversight feedback, etc.
• Coordinate long-term storage archiving while maintaining document integrity in compliance with mandatory retention policies.
• Participate in TMF educational workshops and trainings.

External DIAN-TU Activities

• Support TMF oversight activities of CROs and vendors supporting the DIAN-TU study including identification of systemic quality and completion checks.
• Present summary updates and metrics on external party compliance with TMF requirements and completion status. Support and coordinate delivery of required documentation to pharma partners ensuring appropriate redaction, if/as necessary.
• Performs other duties, as assigned, incidental to the work described herein.

Preferred Qualifications

• ICH-GCP proficiency, CRA experience and practical experience in protocol development (study design).
• Strong knowledge of ICH/GCP with regard to â˜critical/essential documentsâ™ required for Trial Master File (TMF) inclusion.
• Good understanding of the operational execution of clinical protocols.
• Working knowledge of techniques and methodologies used in developing, coordinating, and managing clinical research projects including coordination with external parties, i.e. CROs, vendors, etc.
• Working knowledge of database management and spreadsheets, or similar tracking tools, including ability to learn new software.
• Strong document development skills in MS Office products or other software used for tracking, organization, and metrics reporting. 
• Organizational skills to support systematic tracking of activities and work product.
• Good judgment to maintain confidentiality and ensure integrity of data.
• Able to work effectively in a team environment and be flexible to contribute to the needs of the group.
• 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, and Cores.
• Ability to prioritize work effectively to meet timelines.
• Willing to travel as necessary (i.e. investigator meetings, seminars or company meetings, etc.).

Required Qualifications

Bachelor of Science degree plus four years of clinical or research experience with at least one year of lead or supervisory experience included; eight years of relevant education and work experience may substitute for this requirement.

Grade

C13

Salary Range

$66,700.00 - $103,400.00 / 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.

Accommodation

If you are unable to use our online application system and would like an accommodation, please email CandidateQuestions@wustl.edu 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? Weâ™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 Universityâ™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 â“ 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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