Job Description

Scheduled Hours
40

Position Summary
This position will play a key role in expanding and managing clinical research activities led by Dr. Barbara Trautner. Position will be responsible for developing clinical trial protocols, working closely with investigators to design feasible, compliant studies that align with scientific goals. Will oversee daily operations of Dr. Trautner's research portfolio, ensuring studies are executed in compliance with institutional expectations. Will also serve as a liaison between WashU and partner research sites, building strong collaborations with site investigators and clinical teams to support successful study execution across study-involved locations. Will contribute to grant writing, reporting and communications, assisting with annual reports to funders such as AHRQ, the Neilsen Foundation, and VA R&D, and supporting manuscript and abstract tracking for all research output. Will also organize study-specific meetings, facilitate coordination across teams, and help ensure that deliverables are met on time.

Primary Duties & Responsibilities:

• Manages full scope of study conduct, in collaboration with Administrative Operations, to ensure studies are conducted according to the Code of federal Regulations, Good Clinical Practices, local regulatory requirements and Washington University SOPs.
• Collaborates with all relevant groups to develop and manage clinical project timelines.
• Coordinates and leads meetings with all study team members.
• Plans and participates in investigator meetings, in collaboration with all cross-functional team members.
• Disseminates clinical project communications to all functional groups, as appropriate.
• Contributes to protocol synopsis development and Clinical Operations feasibility assessments.
• Writes study protocols, amendments and administrative changes based on approved protocol synopsis.
• Provides oversight of subcontracts (biomarkers, imaging, data management) which includes communicating expectations and timelines, ensuring deliverables are on time, with no quality issues.
• Determines staffing needs for all projects.
• Ensures training of study team, all performance sites and Cores/Components on study protocol and expectations.
• Provides input to problem-solving and implements corrective action plan when necessary.
• Partners with Administrative Operations and Project Leaders, where applicable, to resolve performance site issues.
• Partners with Administrative Operations, Project Leaders and subcontractors (biomarkers, imaging, data management) for resolution of corrective actions as a result of QA audit and/or regulatory inspections.
• Escalate issues relevant to medical personnel as appropriate for medical monitoring, safety, and exemptions/deviations.
• Manages timelines and maintain project tracking system with current study status and provide accurate progress reports on assigned studies as requested.
• Helps to conceptualize and submit new grant proposals.
• Helps to manage budgets/funds.
• Assists with manuscript preparation and submission.

Working Conditions:
Job Location/Working Conditions

• Normal office environment.

Physical Effort

• Typically sitting at desk or table.

Equipment

• Office equipment.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Required Qualifications

Education:
Bachelor's degree

Certifications:
No specific certification is required for this position.

Work Experience:
Clinical Research And Program Management Including Leadership And Management (5 Years)

Skills:
Not Applicable

Driver's License:
A driver's license is not required for this position.

More About This Job
WashU seeks highly motivated individuals who are able to perform duties in a manner consistent with our core mission and guiding principles.

Preferred Qualifications

Education:
M.S. - Master of Science, Ph.D. - Doctor of Philosophy, Pharm.D. - Doctor of Pharmacy

Certifications:
Registered Nurse - Illinois Department of Financial and Professional Regulation, Registered Nurse - Missouri Division of Professional Registration

Work Experience:
No additional work experience beyond what is stated in the Required Qualifications section.

Skills:
Budget Management, Business Writing, Clinical Procedures, Clinical Research, Clinical Setting, Clinical Study Design, Communication, Confidentiality, Data Integrity, Flexible Mindset, Group Presentations, Medical Writing, Operational Execution, Problem Resolution, Professional Etiquette, Project Implementations, Protocol Development, Sound Judgment, Tactful, Teamwork, Technical Knowledge, Time Management, Travel Scheduling

Grade
G14

Salary Range
$75,200.00 - $128,800.00 / 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 [click to reveal email address] CandidateQuestions@wustl.edu or call the dedicated accommodation inquiry number at [click to reveal phone number]314-935-1149 and leave a voicemail with the nature of your request.

All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.

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.
• Take advantage of our free Metro transit U-Pass for eligible employees.
• 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:

EEO 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.

Washington University is dedicated to building a 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.

Job Tags

Full time, Work experience placement, For subcontractor, Work at office, Local area, Flexible hours,

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