Director Of Prime IRB

Location
Rockville, Maryland
Posted
Jun 29, 2018
Closes
Jul 02, 2018
Function
Executive, Director
Industry
Science
Hours
Full Time

The EMMES Corporation, established in 1977, is a women-owned private Contract Research Organization (CRO). Headquartered in Rockville, Maryland Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

The Director of Prime IRB is newly created position due to growth located in our Rockville, MD or Frederick, MD office. The Director of Prime IRB is responsible for supporting an initiative to provide expanded IRB services to our clientele. In this role, the Director will oversee a wide array of robust IRB services for large, multi-site, multi-protocol clinical trials.

Responsibilities

  • Provide oversight of the Prime IRB portfolio of services, staff and manage Prime IRB clients

  • Advise, recommend and deploy customized IRB infrastructure and human research protection programs according to clientele IRB needs; define integration with sites, sponsors and program structure.

  • Establishes IRB operational objectives and assignments and delegates assignments to subordinate managers; Provide oversight of objectives to determine success of operation.

  • Spearhead the development and modification of Prime IRB policies that affect immediate operation(s) and may also have company-wide effect.

  • Work on complex problems in which analysis of situations require an in-depth evaluation of various factors; develops and administers IRB budgets, schedules and performance requirements.

  • Serves as primary contact with subordinates, outside clients, and functional group managers with the Prime IRB and the Emmes corporation.

  • Interacts with various management levels to identify and timely resolve challenges.

  • Approves IRB Prime documents for external distribution and implements service/functional group and/or corporate processes.

  • Represents company at external meetings for both existing and potential clients and collaborating organizations.

  • Co-authors technical scientific manuscripts, publications, or presentations to promote or support Prime IRB.

  • Attends and presents at outside IRB related conferences to assure currency of knowledge and shares information at role-specific meetings.

  • Manage functional area SOPs and implements changes in project activities; recommends changes in corporate activities as appropriate.

  • Chairs corporate group meetings and provides significant corporate contributions such as strategic leadership and business development.

  • Spearheads staff mentorship for service/functional group personnel on a corporate level.

  • Participates in interviewing and makes hiring decisions and conducts performance reviews for service/functional group staff.

  • Applies knowledge learned at external meetings to improve IRB Prime project or corporate activities and provides strategic direction in adopting industry-wide IRB standards and best practices.

  • Successfully competes for and acquires new or continuing business for Prime IRB.

  • Leads IRB proposal writing efforts and other business acquisition activities as a technical/scientific expert resulting in new business.

Experience

  • Bachelor’s degree in a related field and minimum of 15 years related experience; Alternately 10 years of related experience with a Master’s level or higher degree

  • Demonstrated working knowledge of IRB technical/scientific principles appropriate to the position

  • 5 or more years of management experience of IRB professionals

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The EMMES Corporation is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.