Associate Director Clinical Research - Pediatrics Administration

Position: Associate Director Clinical Research - Pediatrics Central Administration

Scheduled Hours

40

Position Summary

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).

Job Description Primary

Duties & Responsibilities Pediatric Clinical Research Unit Oversight

• 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.

Provide Leadership Within the Department of Pediatrics Clinical Research Enterprise

• 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.

Data and Biostatistics Support

• Assists with data requests.
• Shares with Investigators Biostatistics resources available.

Training, Education, and Quality Improvement

• 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.

Represents Department of Pediatrics on Clinical Research Related Committees

• Attends committee meetings and disseminates information to Department clinical research staff.

Performs other duties as assigned.

Working Conditions

Job Location /Working Conditions

• Normal office environment

Physical Effort

• Typically sitting at a desk or a 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/Professional Licenses:
No specific certification/professional license is required for this position.

Work Experience:

Clinical Research (8 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:

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

Grade

G15

Salary Range

$84,200.00 - $ / 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…