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Location:
Gaithersburg, Maryland, United States
Cambridge, England, United Kingdom
Job reference: R-053561
Posted date: Jun. 18, 2019
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At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Clinical Project Coordinator in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

Position Summary:                                

Responsible for supporting Clinical Operation Team members with the tasks associated with implementation and conduct of clinical studies. Qualified candidates will demonstrate the ability to coordinate and prioritize multiple tasks, have good computer skills, and practical clinical trial experience. 

Major Duties and Responsibilities:

  • Maintain trial master file, study site records and files and ensure compliance with applicable SOPs
  • Create, implement, and maintain systems to track study metrics and general information (ex. OPAL and IMPACT, etc.)
  • Coordinate generation of study metric reports and action logs
  • Review of essential study documents
  • Process study-related documents and materials - to include collation, filing, routing coordination of third-party provider document shipments to AstraZeneca
  • Initiate contract/budget requests and track ongoing status  
  • Schedule team meetings and prepare agendas and minutes
  • Prepare and distribute study-related correspondence
  • Organize and ship study supplies to clinical sites
  • Participate in identification and selection of clinical study sites, including conducting searches of web-based databases
  • Develop study specific procedures and tools
  • Assist clinical operations team with study management
  • Participate in vendor selection and ongoing vendor management
  • Generate purchase orders, process vendor invoices and assist in tracking spend against approved budget
  • Assist in the organization of advisory boards and investigator meetings. Track approvals and completion of required documents.
  • Assist in the clinical trial insurance process. Track approvals, revisions and renewals of certificates
  • Perform other functions as necessary or as assigned 


Requirements/Qualifications: Education:  

  • High School Diploma or equivalent required; Bachelor’s Degree strongly preferred     


Experience:        

  • 2-3 year’s clinical trial experience and at least 1+ year(s) experience in an office or laboratory environment 


Special Skills/Abilities:        

  • Professional demeanor and ability to work as a team member
  • Experience with Microsoft Office Suite (Word, Power Point, Excel)
  • Ability to coordinate and prioritize multiple tasks
  • Demonstrated verbal and written communication skills
  • Demonstrated interpersonal and problem solving skills
  • Proactive approach and the ability to act independently, or as part of a diverse team
  • Understanding of ICH, GCP and relevant regulatory requirements
  • Familiarity with drug names, diagnoses and medical/research terminology
  • Ability to work as part of a global team
  • Willingness to travel to attend periodic meetings.(Travel <10%) 

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer.  AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

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Clinical Project Coordinator
Project, Change, Business Improvement and Strategy Management

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