Novavax
  • 27-Jun-2017 to 26-Sep-2017 (EST)
  • Clinical Development
  • Gaithersburg, MD, USA
  • Full Time - Non-Exempt

Are you ready to work for one of Washington's Top Workplaces?  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.

 

The Clinical Research Associate (CRA), will provide support to the Clinical Project Manager in the execution of one or more phase 1-4 clinical trials from protocol through clinical study report finalization for regulatory submission. Ensure compliance with ICH-GCP, FDA/ EMA, other regulations and SOPs, as applicable. Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards. Responsible for the management of CROs and ensure adherence to scope of work within timelines and budget.

 

Responsibilities include but are not limited to: 

  • Management of discrete aspects of clinical study as designated by Clinical Project Manager (CPM)
  • Assist in the management of 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 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 subject clinical records at the site, and communicate with necessary personnel for data query resolution;
  • Assist CTM 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;
  • Participate in investigator meeting activities (preparation and presentation)
  • Other duties as assigned 

 

Minimum Requirements: 

  • BS/BA degree or equivalent (background in life sciences preferred).
  • Minimum 1 - 5 years' experience in clinical research / operations. Minimum 2 years of clinical monitoring experience a benefit
  • Experience in global trials from start-up to database-lock preferred
  • Experience in management of vendors and CRO's
  • Strong understanding of ICH, GCP and relevant regulatory requirements
  • Strong operational skills with attention to detail
  • Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project
  • Ability travel globally up to 30% of time

 

Novavax, Inc. is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and Matrix-M adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Our product pipeline targets a variety of infectious diseases with vaccine candidates currently in clinical development for respiratory syncytial virus ("RSV"), seasonal influenza, pandemic influenza, and Ebola virus ("EBOV"). We have additional preclinical-stage programs for a variety of infectious diseases. Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden.

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.

We  are  an  equal  opportunity  employer  that  values  diversity  at  all  levels.  All individuals, regardless of personal characteristics, are encouraged to apply.

Novavax
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