Clinical Trial Associate I

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Working at Abbott   At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:  Career development with an international company where you can grow the career you dream of.  Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.  An excellent retirement savings plan with a high employer contribution  Tuition reimbursement, the  Freedom 2 Save  student debt program, and  FreeU  education benefit - an affordable and convenient path to getting a bachelor’s degree.  A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.   A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

This position works out of our Madison, WI location in the Cancer Diagnostics division. This position is responsible for assisting in the execution of clinical trials by providing quality administrative and project management support. This position will coordinate with all members of the Clinical Affairs team and internal and external stakeholders to successfully execute the clinical study plans of the company. What You’ll Work On   Include, but are not limited to, the following: Collect essential documents and review for completeness and compliance with Standard Operating Procedures, the protocols, and appropriate regulations; review Trial Master File (TMF) inventory for missing and expiring documents. Interact with clinical study sites to support study start-up, execution, and close-out activities. Create and maintain study related trackers, including but not limited to, enrollment, study supplies, receipt of samples, and site information. Coordinate the ordering, tracking, and accountability of clinical supplies, including investigational product materials, equipment, and special-order items as requested. Review for completeness and route legal documents for execution. File all versions in document management database. Draft study documents (study trackers, templates, presentations, etc.) as requested. Support case report form (CRF) development, participate in user acceptance testing (UAT) for electronic data systems and review related data management documents, as applicable. Represent Exact Sciences as a customer advocate/liaison both internally and externally. Coordinate study start-up, execution, and close-out activities, or Investigator Meetings, as requested. Responsible for completing assigned tasks to support study timelines and metrics with minimal ongoing direction. Identify and report problems, investigate alternatives, and make recommendations for resolution and process improvements. Responsible for organizing cross-functional project meetings. Distribute agendas, take and distribute meeting minutes.  Provide follow-up support and data collection for Research and Development teams to advance project objectives. Initiate purchase requests liaise with Accounts Payable and vendors as needed.  Provide support to Clinical Trial Manager for clinical study budget review, tracking, and maintenance. Must be able to work both independently and collaboratively as part of the clinical study team to meet study objectives and timelines. Author and provide input to Clinical Affairs business processes. Maintain a working understanding of current