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Site Contract Associate (2 Positions)

Location Wilmington, Delaware, United States Job ID R-060543 Date posted 09/05/2019

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 Site Contract Associate – Study Administrator, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

The Site Contract Associate/Study Administrator (SA) assists in the coordination and administration of the Confidentiality Agreement (CDA) study start up activities for US sites to ensure quality and consistency of CDA terms in a timely manner.

Duties May Include:

  • Assist in coordination and administration of clinical studies from the start-up to execution and close-out.
  • Populate and negotiate acceptable CDA terms with sites identified by the study team within electronic contracting system (Falcon).
  • Operational responsibility for finalizing CDAs including tracking of documents within Falcon and notifying the clinical teams when agreements are finalized.
  • Provide appropriate team members with weekly reports on CDA status per study.
  • Follow up with sites regarding outstanding CDAs on regular basis.
  • Contribute to the production and maintenance of CDA templates, ensuring template and version compliance.
  • Set-up, populate and accurately maintain information in FALCON.
  • Coordinate CDA tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.
  • Contribute to department and study team meetings. Liaise with internal and external participants and/or vendors.
  • Assist with CSA AME creation, negotiation, execution and tracking when requested.

Minimum Requirements:

  • Completed high school
  • Previous clinical study experience with CDA/start up process
  • Experience working with clinical sites
  • Proven organizational and administrative skills
  • Computer proficiency
  • Very good knowledge of spoken and written English

Preferred Skills and Experience Requirements:

  • BA or BS in relevant discipline related to Clinical Research or Business Management
  • Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
  • Ability to develop advanced computer skills to increase efficiency in day-to-day tasks
  • Good interpersonal skills and ability to work in an international team environment
  • Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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  • Clinical Development, Wilmington, Delaware, United StatesRemove

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.