"Clinical Research Specialist - Pediatrics Central Administration"

Position Summary

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.

Required Qualifications

Education:

Bachelor’s degree or combination of education and/or experience may substitute for minimum education.

Certifications/Professional Licenses:

Basic Life Support - American Heart Association, Basic Life Support - American Red Cross

Work Experience:

Clinical Or Research (4 Years), Supervisory (1 Year)

More About This Job

• 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).

Preferred Qualifications

Skills:

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

Grade

C13

Salary Range

$68,100.00 - $105,500.00 / 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.

Scheduled Hours

40