ISS Coordinator

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At Exact Sciences, we're helpingchange 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 the execution of numerous investigator sponsored studies (ISS/IIS) by providing quality administrative and clinical trial 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.

This position may be remote.

Essential Duties

Include, but are not limited to, the following:

• Independently and efficiently manage a high volume of investigator sponsored studies (ISS/IIS), balancing competing priorities and ensuring timely progress toward operational goals for all studies.
• Provide end-to-end operational support for investigator sponsored studies, including contracting, timeline development, sample oversight, kit ordering, budget management and forecasting, issue resolution, site payments, and ensure efficient study progress and compliance.
• Work independently with a high degree of autonomy to manage day-to-day trial operations, exercise sound judgment and address study challenges proactively to ensure timelines, compliance, and quality standards are met.
• Thrive in a fast-paced environment, efficiently managing multiple investigator sponsored studies with competing deadlines while maintaining compliance and attention to detail.
• Partner effectively with principal investigators, physicians, external collaborators, and cross-functional study teams to coordinate study activities, progress tracking, issue resolution, and ensure clear, timely communication throughout the study lifecycle.
• Operate effectively in ambiguous or fast-changing situations, using critical thinking and initiative to determine next steps, resolve challenges, and maintain study momentum.
• 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. EPIC, 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.
• Support 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.
• 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.

Minimum Qualifications

• 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 Qualifications

• Experience independently managing numerous investigator sponsored studies (ISS/IIS) from initiation through closeout.
• 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).

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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