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Senior Clinical Research Associate

Published
April 13, 2018
Location
Gaithersburg, Maryland
Category
Default  
Job Type

Description

At Novavax, a clinical-stage vaccine company, we are creating tomorrow's vaccines today! We seek to attract, develop, and retain talented people who share our passion for science, medicine, and human health. We foster an environment of teamwork and collaboration, built on a culture that values and appreciates its employees. We are a fast-paced company that provides employees with opportunities to achieve personal and professional goals while also maintaining a balance between work and personal life.

We are seeking a Sr. Clinical Research Associate to work in our Gaithersburg, MD Clinical Operations Department. The Senior CRA will assist in the coordination of activities related to the conduct of clinical trials and may participate in the development of clinical protocols, CRFs, Investigator Brochure's and associated clinical materials. This position is responsible for the oversight of clinical monitoring activities conducted by outsourced CRAs. The Senior CRA will review and verify clinical data from studies, and ensure that studies comply with GCP standard and FDA regulations.

Responsibilities include but are not limited to:

  • Independent implementation and management of research projects as assigned;
  • Manage CROs and other CRAs at a project level;
  • Oversee the monitoring of the clinical study to assure adherence to protocol, GCP, FDA regulations and overall clinical objectives including study prequalification, initiation, interim and close-out visits;
  • Train contract and in-house CRAs on study protocols, study procedures, and monitoring SOPs;
  • Review and track trip reports, site follow-up letters/documentation, track site as well as CRA progress and report status weekly to Clinical Project Manager (CPM);
  • Assist CPM in coordination of contracts, budgets and financials tracking
  • Coordinate study supplies forecasting and distribution;
  • Train and observe clinic personnel with regards to vaccine preparation and administration procedures;
  • Verify accuracy of clinical data through comparison of the case report forms to patient clinical records at the site, and communicate with necessary personnel for data query resolution;
  • Assist CPM with study start up procedures, logistics, document preparation, and site selection;
  • Assist in the preparation of study related documents;
  • Co-monitor with other CRAs as required;
  • Function as a liaison with collaborators, CROs and investigator sites to ensure progress of studies, budgets, contracts, enrollment, and data management;
  • Interact with project teams, and assist in the preparation and follow-up for project meetings;
  • Assist in preparation and presentations for investigator meetings;
  • Other duties as assigned

Minimum Requirements:

  • BS/BA degree or equivalent (background in life sciences preferred)
  • Minimum of 5yrs experience in clinical research/operations.  Minimum of 2yrs of regional site monitoring experience
  • Detail oriented with strong organizational skills
  • Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project
  • Ability to travel globally up to 30% of time

Novavax, Inc. is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Using innovative proprietary recombinant nanoparticle vaccine technology, we produce vaccine candidates to efficiently and effectively respond to both known and emerging disease threats. Our vaccine candidates are genetically engineered three-dimensional nanostructures that incorporate recombinant proteins critical to disease pathogenesis.

Our product pipeline targets a variety of infectious diseases, with clinical vaccine candidates for respiratory syncytial virus (RSV) and Ebola virus (EBOV), and preclinical programs for Zika virus (ZIKV), seasonal influenza and a combination respiratory vaccine candidate, as well as other infectious disease vaccine candidates.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

 

Equal Opportunity Employer/Veterans/Disabled

 

Novavax, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://www.applicantpro.com/j/773512-222192

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