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Director of Research

2 months ago

Virginia Beach, United States Urology Of Va Full time

Description:

Company Overview

Urology of Virginia (UVA) has a long history of providing comprehensive and quality care to the entire Hampton Roads region, including northeastern North Carolina. Our clinical care team consists of board-certified urologists, most of whom are fellowship-trained, nationally recognized, awarded, and published. Working in a team-based environment, our mission is to help patients optimize their urological health.

Job Overview

We are seeking a Director of Research who will be responsible for the management and administrative direction of the clinical research department at Urology of Virginia. This employee will direct the clinical research operations in administrative, budgetary and fiscal matters.

Duties and Responsibilities

Administrative Responsibilities:

Possesses a full understanding of the clinical research process, study designs and regulatory standards of Good Clinical Practice (including applicable Code of Federal Regulations/ ICH Guidelines)
Negotiates confidentiality agreements with pharma, device and diagnostic companies
Reviews protocols and performs feasibility assessments for clinical trials
Schedules and conducts site qualification and site initiation visits with study sponsor representatives
Negotiates and approves all budgets and trial agreements for clinical trials
Negotiates and approves all subcontracts with collaborators/ investigators and facilities
Designs, implements, and manages a system for organizing, planning, and controlling work flow related to all clinical research activities. Assign trials to research staff members based on their experience and workload capabilities
Monitors all Urology of Virginia Research and academic financial accounts; tracks revenue and expenses of each individual trial; reviews monthly profit/loss statements for accuracy
Invoices study sponsors for trial related expenses and reconciles all payments for accuracy and completeness
Maintains standard operating procedures manual; revises and updates procedures based upon regulations and guidance documents
Provides continuous communication on the study conduct, pre study through post study, acts as a liaison between Urology of VA and national and international pharmaceutical and medical device companies
Attends virtual LUGPA research director bimonthly meetings; attends annual LUGPA meeting in person
Attends the annual AUA meeting to meet with current trial sponsors and to network with potential collaborators on future trials
Maintains ongoing dialogue with Practice Management, Research Committee and the principal investigators on enrollment, progress, and completion of clinical trials
Maintains cooperative relationships with EVMS and local healthcare facilities for collaboration purposes
Maintains data to prepare reports, and to provide statistical information on academic and clinical research activities as required by the Practice Administrator, Research Committee and officers of the Schellhammer Urological Research Foundation (SURF)
Participates in the development and writing of proposed protocols with emphasis on areas concerning protocol management: budget, equipment, personnel, supplies, marketing, and recruitment

Supervisory Responsibilities:

Builds and maintains a positive work environment with dedicated team members
Interviews, hires, trains and oversees employees of the Research department. Also, discipline and if necessary, dismiss employees
Maintains knowledge of overall status of all department clinical trial activities
Ensures investigators and staff are properly trained in required IRB or sponsored programs
Prepares for and participates in FDA inspections
Requirements:
Bachelors degree in a health or science related field or RN/BSN
At least 6 years of clinical research experience and 2 years of management experience
CCRP or CCRC with 8+ years of research experience may be considered in lieu of education requirement

Equal employment opportunity for all is a very important philosophy for our practice. We will evaluate all applicants and employees without regard to race, color, religion, national origin, sex, age, non-disqualifying disability, history of military service, genetic information, or any other status protected by law. This policy applies to all employment practices, including, but not limited to, recruitment, employment, assignments, promotions, reassignments or transfers, disciplinary matters, establishment of rates of pay or other compensation, and selection for training programs.

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