Clinical Project Coordinator (Contractor)


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Gaithersburg, MD

Job Description

As posted by the hiring company

Job Overview:

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases.  We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform.  Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

Summary of the Position:

We are seeking a full-time Clinical Project Coordinator to provide clinical trial coordination support to the study team, assist clinical operations project leaders in tracking activities, and to manage clinical operation study documentation including the electronic Trial Master File of assigned clinical trials for our rapidly expanding vaccine development programs. This position reports to the Senior Director / Director Clinical Project Management.

Location Flexible.

Responsibilities include but are not limited to:

  • Build working relationships with members of the clinical study team and other key stakeholders to coordinate tracking and communication for one or more clinical trials. Coordinate the study team meetings including generation of meeting minutes, updates, and management of associated study team trackers (e.g., action, decision, roster, risk, etc.) as assigned by the Clinical Project Manager.
  • Perform regular QC of the clinical operation documentation within the clinical study electronic Trial Master File (eTMF) for assigned clinical trials.
  • Partner with Clinical Project Manager to document CRO oversight activities including active management of information detailed in CRO Oversight Workbook.
  • Coordinate with key internal stakeholders, including Clinical Project Manager and Business Operations, to:
      • monitor the project plan schedule and interact regularly with the clinical study team to track the status of clinical trial activities and the accomplishment of key milestones.
      • assess and communicate changes to study level information needed to maintain the Clinical Trial Management system information.
  • Assist with the development, management, and maintenance of the internal study team SharePoint site.
  • Execute other duties as assigned by the study team to support clinical trial quality, compliance with SOPs, and regulatory guidelines.
  • Other study tasks as assigned by the Senior Director / Director, Clinical Project Manager or Clinical Project Manager

Minimum requirements:

  • Bachelor's Degree required; degree in biological or chemical sciences preferred
  • 1-3 years of experience in the biotech, pharma, or CRO industries.
  • Knowledge and work experience that required application of ICH/GCP guidelines.
  • Solid written and oral communication skills,
  • Proficient in MS Office, including excel and PowerPoint.

Preferred Qualifications:

  • Clinical operations experience
  • Working knowledge of Veeva Vault eTMF environment
  • Experience managing information for Clinical Trial Management Systems and MS Project,
  • Prior experience with management of content in SharePoint.
  • Comfortable working with high-performing cross-functional teams
  • Ability to multi-task different activities across one or more clinical studies
  • Ability to establish collaborative working relationships across organizational disciplines, and throughout the organizational hierarchy
  • Able to work on a dynamic, fast-paced environment, operating independently and as part of a team

Novavax offers a base salary, annual bonus, equity grants, 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 is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.

Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.