Director, NHLBI IRB - Remote

Location
Rockville, Maryland
Salary
Competitive
Posted
Jan 02, 2022
Closes
Feb 01, 2022
Ref
3130
Function
Executive, Director
Industry
Science
Hours
Full Time
Director, NHLBI IRB

US Remote Worker

Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Director of the National Heart, Lung, & Blood Institute (NHLBI) Combined Data Science Institutional Review Board (CDS-IRB) is newly created position due to growth located in our Rockville, MD or Frederick, MD office. The Director of the NHLBI CDS-IRB is responsible for supporting the NHLBI IRB for Extramural Research Program. In this role, the Director will oversee IRB services for a trans-NIH effort to launch a Data Commons that will accelerate new biomedical discoveries by providing a cloud-based platform to store data generated from biomedical research where investigators can perform novel scientific research.

Responsibilities
  • Provide oversight of all operations of the NHLBI IRB including the development/revisions of policies and procedures and the review of submitted protocols in compliance with federal regulations
  • Manage Emmes' NHLBI IRB support staff
  • Manage communications and serve as primary contact between the IRB, NHLBI, research staff, and IRB Operations Office
  • Establishes IRB operational objectives and assignments and delegates assignments to support staff
  • Oversee the management of regulatory documents appropriately to maintain accurate and complete records of all IRB activities
  • Oversee the maintenance of databases for tracking studies and IRB submissions
  • Serve as a resource to the human subjects protection program to questions on preparing submissions and compliance with SOPs
  • Assist in the development of tools and educational resources to support the IRB's review of research and in training of IRB members
  • Work on complex problems in which analysis of situations require an in-depth evaluation of various factors
  • Approves NHLBI documents for external distribution
  • Attend and present at outside IRB related conferences to assure currency of knowledge and shares information at role-specific meetings
  • Participate in interviewing and makes hiring decisions and conduct performance reviews for service/functional group staff
  • Participate in IRB proposal writing efforts


Experience
  • Bachelor's degree in a related field and minimum of 10 years related experience
  • Demonstrated working knowledge of IRB technical/scientific principles appropriate to the position
  • 3 or more years of management experience of IRB professionals
  • Strong Project management skills, including ability to anticipate and prioritize next steps with minimal direction


Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
  • Unlimited Approved Leave


  • Tuition Reimbursement


  • 401k & Profit Sharing Plan
  • Work From Home Anywhere in the US


  • Maternal/Paternal Leave


  • Casual Dress Code & Work Environment


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The Emmes Company, LLC 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.

Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.