Clinical Trial Associate I

Working at Abbott

At Abbott you can do work that mattersgrowand learn care for yourself andyourfamily be your true selfand live a full also have access to:

• Career development with an international companywhere you can grow the career you dream of.

• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.

• An excellent retirement savings plan withahigh employer contribution

• Tuition reimbursementtheFreedom 2 Savestudent debt programandFreeUeducation benefit- an affordable and convenient path to getting a bachelors degree.

• A company recognized as a great place to work in dozens of countriesworldwideandnamed 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 asthebest place to work for diversity working mothers female executives and scientists.

The Opportunity

This position worksout ofour Madison WI locationin theCancer 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 YoullWork 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 SOPs work instructions applicable regulations and guidance documents such as FDA Code of Federal Regulations (CFR) and International Council on Harmonisation (ICH) Guideline for Good Clinical Practices (GCP).
• Maintain applicable clinical study data in Clinical Trial Management System.
• Ability to organize present and convey problems or issues.
• Strong verbal and written communication skills.
• Effective presentation skills.
• Ability to interface and work effectively within team and department with changing priorities.
• Ability to frequently and accurately communicate with co-workers customers and vendors via the telephone or by email.
• Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.
• Ability to manage multiple deadlines.
• Analytical problem solving and decision-making skills.
• Excellent attention to detail and organizational skills.
• Uphold company mission and values through accountability innovation integrity quality and teamwork.
• Support and comply with the companys Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work designated schedule.
• Ability to work nights and/or weekends.
• Ability to work on a mobile device tablet or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to travel 5% of working time away from work location may include overnight/weekend travel.

RequiredQualifications

• Bachelors degree in the life sciences or related field; or Associates degree in the life sciences or related field and 2 years of relevant experience in lieu of Bachelors degree.
• General knowledge of applicable clinical research principles and requirements including GCP and ICH guidelines.
• Proficient in using basic software applications including Microsoft Office (Word - generate documents and tables Excel - create and modify spreadsheets create complex formulas etc. Email preferably Outlook) and various search engines for conducting Internet searches.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

PreferredQualifications

• 1 year of experience in a clinical research setting (Clinical Trial Assistant Study Coordinator or similar).
• Experience in a healthcare clinical or science related field.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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