Safety Monitor

Location
Washington D.C.
Posted
Oct 12, 2018
Closes
Oct 15, 2018
Function
Other
Industry
Science
Hours
Full Time

The Emmes Corporation, established in 1977, is a privately-owned 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. Emmes is seeking a Safety Monitor.

Project

The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership in research, training, and education to prevent and treat heart, lung, blood and sleep disorders. The NHLBI is convening a Cure Sickle Cell Disease Initiative (CureSCi), aimed at finding innovative ways to support discovery and development of efficacious genetic therapeutic approaches and bring them to scale in clinical populations to accelerate finding curative treatments for Sickle Cell Disease (SCD). The NHLBI is working with The EMMES Corporation to establish a Coordinating Center (CC) for the CSCI and to engage key staff of this initiative.

Responsibilities

  • Preparation and follow up with project activities (call, web seminars, workshops, symposiums)
  • Attend and participate in weekly internal staff meetings for project updates and tasks assignments
  • Attend project Executive and Governance Committee calls with NHLBI as necessary
  • Attend scientific meetings and various conferences on behalf of the project
  • Act in the capacity of an integral, core member of the project’s Patient Engagement and Outreach Sub-committee
  • Assist in the preparation of sub-committee conference calls and meeting minutes.
  • Assist in the preparation of project-required reports
  • Assist in writing, editing, and tracking project-related publications and educational materials
  • Provide patient education and clinical care perspectives to the project
  • Complete patient and provider listening sessions in the clinical setting
  • Contribute to the development and implementation of the safety Case Report Forms (CRF) and Safety Monitoring Plans (SMP) for the project
  • May also serve as a member of the corporate Pharmacovigilance team, which includes additional tasks such as review of safety events and MedDRA coding
  • Ensure adherence to project and corporate standard operating procedures (SOPs), as well as Federal Regulations and ICH/GCP in maintaining data integrity and quality throughout the project

Experience

  • Bachelor’s degree in nursing (BSN) with a minimum of one year clinical experience Experience in clinical trials research preferred Prior experience with sickle cell disease is a definite plus Excellent knowledge of medical terminology Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way, particularly as relates to explaining information to patients Excellent oral and written communication skills with the ability to effectively communicate and coordinate with internal and external clients and colleagues Skills in prioritization, problem solving, organization, decision making, time management and planning Ability to do national travel 1 to 3 days approximately 1-2 times per month Ability to work as a team member and function on a cross-functional team

 

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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.

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