Associate Director Clinical Research - Pediatrics Central Administration

Washington University in St. Louis • Ann Arbor, MI

20d • Onsite

About The Position

Under the direction of the Vice Chairs of Clinical Investigation and Director Research/Business Administration this position is responsible for providing leadership within the Department of Pediatrics clinical research enterprise and responsible for the clinical research activity of the Pediatric Clinical Research Unit (PCRU).

Requirements

• Education: Bachelor's degree
• Work Experience: Clinical Research (8 Years)
• Skills: Not Applicable
• Driver's License: A driver's license is not required for this position.

Nice To Haves

• Education: Master's degree
• Certifications/Professional Licenses: Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (ACRP), Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SOCRA), Clinical Research Associate (CRA) - Association of Clinical Research Professionals (ACRP), Clinical Research Management (CRM) - Association of Clinical Research Professionals (ACRP), Clinical Research Professional (CRP) - Association of Clinical Research Professionals (ACRP), Registered Nurse - Illinois Department of Financial and Professional Regulation, Registered Nurse - Missouri Division of Professional Registration
• Work Experience: No additional work experience unless stated elsewhere in the job posting.
• Skills: Building High Performance Team, Clinical Research Organizations, Compliance Requirements, Data Reporting, Diplomacy, DP Operations, External Stakeholders, Financial Acumen, Grants Management, Grant Writing, Implementing Policies, Internal Stakeholders, Interpersonal Communication, Leadership, Project Planning, Strategic Planning, Subsidies

Responsibilities

• Manages the PCRU and the day-to-day functions of the unit.
• Recruits, hires, trains, manages and reviews clinical research staff.
• Makes recommendations and participates in the development of and implements decisions and policies and procedures for the PCRU.
• Monitors financial performance of the unit and helps develop rates.
• Monitors compliance of the clinical research division with the IRB, federal mandates, grant and industry compliance; identifies areas needing improvement and suggests solutions to problems.
• Assists with compliance monitoring and audits.
• Aids in the strategic planning of the PCRU.
• Responsible for research education and training of clinical research staff to include the development of a research manuals and training program to maintain research compliance.
• Ensures regulatory compliance across studies.
• Collaborates with sponsors and clinical research teams on various initiatives.
• Assists study teams with the completion of site feasibility questionnaires.
• Provides guidance to Research Administrators and Clinical Research Team Members on Industry Clinical Trial budget development.
• Assists Research Administrators and Clinical Research Team Members with clinical study billing and requests from industry sponsors.
• Acts as liaison between Department of Pediatrics and Center for Clinical Studies when appropriate.
• Acts as liaison in matters relating to clinical research activities between the department, ICTS, the School of Medicine and external agencies.
• Assists with data requests.
• Shares with Investigators Biostatistics resources available.
• In connection with the OVCR office, HRPO, and others, develops and disseminates policies and procedures for human subjects research.
• Conducts risk-based self-monitoring for investigator-initiated, NIH-funded studies.
• Facilitates workforce development among clinical research staff in the department through seminars and providing research updates.
• Attends committee meetings and disseminates information to Department clinical research staff.
• Performs other duties as assigned.

Benefits

• 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 challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees