Clinical Research Specialist - Pediatrics Central Administration

Washington University in St. Louis•Ann Arbor, MI

About The Position

Provides leadership and oversees clinical research studies coordinated by the Pediatric Clinical Research Unit (PCRU). Serves as a resource to provide comprehensive information to clinical research staff by promoting a smooth operation of clinical research; responsible for preparation of budgetary reports and ensures billing and regulatory compliance standards are maintained; may supervise clinical research staff. Job Description Primary Duties & Responsibilities: Provide leadership to PCRU staff acting as the Research Coordinator for Investigator Initiated and Industry Sponsored Clinical Research studies carried out by Principal Investigators. Works with PI to perform research protocol. Implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes assessments and determinations of participants’ progress in the study; analyzes, investigates and reports adverse events; makes decisions as when to notify physicians of issues, when to stop participant inclusion and/or to make and/or recommend adjustment of the protocol of particular participants; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency. Assists in the preparation of amendments to protocols and/or modifications to study design as appropriate. Serves as a resource to the clinical research staff, ensuring appropriate procedures and explains policies and procedures; ensures that research projects are completed according to IRB and federal guidelines. Develops and implements policies and procedures; provides comprehensive direction to clinical research personnel; may participate in the hiring, training and evaluation of clinical research staff. Provides Study Coordinator functions and performs all duties associated with the coordination and implementation of clinical research study/projects, data collection and the management of data generated by study protocols. Researches and recommends new methods and procedures to maintain standards and improve quality. Performs other duties as assigned. 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.

Requirements

Bachelor’s degree or combination of education and/or experience may substitute for minimum education.
Basic Life Support - American Heart Association, Basic Life Support - American Red Cross
Clinical Or Research (4 Years)
Supervisory (1 Year)
Basic Life Support certification must be obtained within one month of hire date.
Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements).

Nice To Haves

Analytical Thinking
Clinical Research
Interpersonal Communication
Leadership
Oral Communications
Prioritization
Problem Solving
Written Communication

Responsibilities

Provide leadership to PCRU staff acting as the Research Coordinator for Investigator Initiated and Industry Sponsored Clinical Research studies carried out by Principal Investigators.
Works with PI to perform research protocol.
Implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes assessments and determinations of participants’ progress in the study; analyzes, investigates and reports adverse events; makes decisions as when to notify physicians of issues, when to stop participant inclusion and/or to make and/or recommend adjustment of the protocol of particular participants; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency.
Assists in the preparation of amendments to protocols and/or modifications to study design as appropriate.
Serves as a resource to the clinical research staff, ensuring appropriate procedures and explains policies and procedures; ensures that research projects are completed according to IRB and federal guidelines.
Develops and implements policies and procedures; provides comprehensive direction to clinical research personnel; may participate in the hiring, training and evaluation of clinical research staff.
Provides Study Coordinator functions and performs all duties associated with the coordination and implementation of clinical research study/projects, data collection and the management of data generated by study protocols.
Researches and recommends new methods and procedures to maintain standards and improve quality.
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.

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