Exact Sciences · 7 hours ago
Clinical Trial Associate II
Madison, WI
Full-time
Hybrid
Entry, Mid Level
$76K/yr - $125K/yr
2+ years expExact Sciences is dedicated to changing how the world prevents, detects, and guides treatment for cancer. The Clinical Trial Associate II will assist in the execution of clinical trials by providing administrative and project management support, contributing to documentation development, and coordinating with the Clinical Affairs team and stakeholders to execute clinical study plans.
BiotechnologyHealth DiagnosticsManufacturingMedical
No H1B
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
Qualification
Required
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
Preferred
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)
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
Company
Exact Sciences
Exact Sciences offers a portfolio of cancer screening and diagnostic tests that span from early detection to treatment monitoring.
5001-10000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.75B2025-06-20Acquired
2024-04-11Post Ipo Debt· $620.7M
2023-02-23Post Ipo Debt· $500M
Leadership Team
Kevin Conroy
Chairman & CEO
Aaron Bloomer
Executive Vice President, CFO
Recent News
2026-01-23
legacy.thefly.com
2026-01-23
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