The Prime Review Board, LLC (Prime) is hiring for a Director of Prime located in our Rockville, Maryland office. The Prime Review Board is an independent IRB that provides ethics consultation and regulatory guidance to clients sponsoring multi-site trials. Prime builds collaborations across communities to address the complex ethical problems that arise in the design, conduct, and analysis of clinical research.
The Prime Review Board, LLC is a subsidiary of The Emmes Company, LLC. Emmes was established in 1977, is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, 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.
The Director of Prime IRB is responsible for building Prime IRB service offerings through 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.
Provide oversight of the Prime IRB portfolio of services, staff and manage Prime IRB clients.
In collaboration with the business development team, proactively build and expand Prime business opportunities and offerings.
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.
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
Experience with a single IRB; Commercial IRB experience preferred
5 or more years of management experience of IRB professionals
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The Emmes Company 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.
Internal Number: 2408
About The Emmes Company LLC
The Emmes Company, LLC, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Rockville, Maryland. Emmes is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research.