Clinical Trial Associate II

Exact Sciences • Madison, WI

6d • $76,000 - $125,000 • Remote

About The Position

At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview This position is responsible for assisting in the execution of clinical trials by providing quality administrative and project management support and contributing to documentation development. 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. This position may be remote.

Requirements

• Bachelor’s degree in the life sciences or a related field; or high school degree/general education diploma and 4 years of relevant experience in lieu of Bachelor’s degree.
• 2+ years of experience in a clinical research setting.
• Thorough knowledge of applicable clinical research principles and requirements, including GCP and ICH guidelines.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Nice To Haves

• Experience in a healthcare, clinical, or science related field.
• Experience mentoring junior team members.
• 3+ years of experience in a clinical research setting (Clinical Affairs Associate, Clinical Trials Associate, Study Coordinator, or similar).

Responsibilities

• Contribute to clinical study protocol development by drafting/updating protocol synopsis and/or assisting with completion of protocol revisions, as requested.
• Assist with the development of or provide feedback on clinical study project plans, as requested.
• Contribute to development of regulatory documents (e.g., Annual Report).
• Provide project-specific systems administration support (e.g., SampleMinded).
• 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.
• Draft clinical site visit materials, as requested.
• Review study site visit reports.
• 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.
• Proactively and autonomously problem-solve, escalate unresolved issues to senior staff and provide recommendations for resolution.
• Author Clinical Affairs business processes and provide input to work instructions and Standard Operating Procedures (SOPs).
• 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.
• Assist with the onboarding and training of Clinical Trial Associates.
• 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.
• 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 company’s 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 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 and means to travel between Exact Sciences locations.
• Ability to travel 10% of working time away from work location, may include overnight/weekend travel.

Benefits

• paid time off (including days for vacation, holidays, volunteering, and personal time)
• paid leave for parents and caregivers
• a retirement savings plan
• wellness support
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level