Clinical Research Project Manager II - Cardiology
Washington University in St. Louis
- # Clinical Research Project Manager II - CardiologyApply: On Campus/Onsite: Washington University Medical Campus: Full time: Posted Today: JR97498# **Location**SAINT LOUIS, MO 63110# **Scheduled Hours**40# **Position Summary**Responsible for the advanced operational planning, oversight, and strategic execution of complex, interdisciplinary clinical research studies spanning multiple departments, sites, and/or institutions. Serves as a senior subject matter expert and primary point of accountability for all aspects of study conduct, quality, and compliance. Provides mentorship and direct supervision to junior research staff. Leads the development of new grant proposals, manages complex study budgets, and plays a central role in disseminating research findings through publications and presentations. Represents the research program to external stakeholders, funding agencies, and regulatory bodies.# **Job Description****Primary Duties & Responsibilities:*** May perform duties inclusive of those delegated to a Clinical Research Project Manager I.* Leads the full scope of multiple concurrent, complex clinical research studies, ensuring studies are conducted according to the Code of federal Regulations, Good Clinical Practices, local regulatory requirements and Washington University SOPs.* Serves as the primary operational lead and institutional representative for assigned studies, acting as the central point of contact for sponsors, regulatory agencies, and collaborative partners.* Develops, implements, and continuously refines study-wide operational strategies, timelines, and quality frameworks in collaboration with PIs, co-investigators, and central research administration units.* Maintains current knowledge of evolving domestic and international clinical research regulations and guidance documents, and applicable state and local requirements; proactively conducts gap analyses to assess the impact of regulatory changes on the assigned studies and the broader research program; develops, implements, and monitors corrective systems, updated SOPs, and training initiatives to close identified gaps and ensure sustained compliance across all sites and functional teams.* Demonstrates working knowledge of international clinical research regulations and guidelines applicable to assigned studies, and other country-specific requirements; advises study teams on when and how international requirements apply – particularly in multi-national trials or studies with international data transfer, biologics, or device components – and coordinates with regulators affairs and legal counsel as needed to ensure compliant study conduct across all applicable jurisdictions.* Leads investigator meetings, kick-off meetings, and cross-functional study team meetings; serves as the primary facilitator for complex multi-site coordination efforts.* Takes primary responsibility for protocol development, including drafting and finalizing study protocols, amendments, informed consent documents, and administrative changes; reviews submissions prepared by junior staff.* Leads feasibility assessments and contributes substantively to the development and writing of new grant proposals, including budget justifications, specific aims, and research strategies.* Manages complex study budgets and funds independently, including oversight of subcontract budgets, reconciliation, forecasting, and reporting to funding agencies; identifies and resolves budget discrepancies.* Directs staffing planning for all assigned projects.* Designs and leads comprehensive training programs for study teams across all performance sites and Cores/Components, ensuring uniform understanding of protocol requirements and institutional expectations. .* Independently identifies, evaluates, and resolves complex study related problems; develops and implements corrective action plans resulting from QA audits, regulatory inspections, or performance issues.* Oversee internal quality control systems and conducts regular audits of study conduct, data quality, and regulatory documentation across the portfolio.* Manages timelines and maintains project tracking systems across a portfolio of studies; produces executive-level progress reports and presentations for investigators, sponsors, and institutional leadership.* Leads or co-leads manuscript preparation, submission, and revision; coordinates authorship contributions and ensures timely dissemination of research results.* Represents the institution at national investigator meetings, regulatory agency interactions, and sponsor communications; builds and maintains strategic external relationships.* Performs other duties incidental to the work described above.* Demonstrates confidence in presentation skills. **Working Conditions**Job Location/Working Conditions* [select one of the following] Position is [in-person] [hybrid] [remote].* Normal office environment.* Ability to travel to various on- and off-campus locations. Physical Effort* Typically sitting at desk or table.* Occasional lifting (25lbs or less). Equipment* Office equipment.* Lab/research equipment.* Clinical/diagnostic 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 or combination of education and/or experience may substitute for minimum education.**Certifications****/Professional Licenses****:**No specific certification/professional license is required for this position.**Work Experience:**Clinical Research And Program Management, Including Leadership And Management (5 Years), Supervisory (1 Year)**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:**No additional education unless stated elsewhere in the job posting.**Certifications****/Professional Licenses****:**No additional certification/professional licenses unless stated elsewhere in the job posting.**Work Experience:**No additional work experience unless stated elsewhere in the job posting.**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# **Grade**G14# **Salary Range**$75,200.00 - $128,800.00 / AnnuallyThe 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 View email address on click.appcast.io or call the dedicated accommodation inquiry number at View phone number on click.appcast.io 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:
- J-18808-Ljbffr Washington University in St. Louis
Vacancy posted 3 hours ago
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