Summit Therapeutics, Inc. · 5 hours ago
Clinical Trial Associate
Princeton, NJ
Full-time
Onsite
Entry Level
$97K/yr - $114K/yr
2+ years expSummit Therapeutics, Inc. is a biopharmaceutical oncology company dedicated to improving quality of life through innovative clinical studies. The Clinical Trial Associate will support the daily workflow of clinical operations activities, providing administrative support to study teams and ensuring compliance with regulatory requirements.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Provides administrative support to the clinical operations study team, including managing meeting logistics, creating agendas, and drafting meeting minutes
Executes tasks as assigned by the Clinical Operations Manager, including study budget forecasting and tracking
Ensures accurate and timely documentation, including eTMF management, study contracts and financial records in compliance with ICH-GCP, company policies and regulatory requirements
Coordinates clinical operations activities across cross-functional teams, including contract management, vendor oversight, site start-up and activation, protocol deviation
Creates and maintains study-related materials, such as country and site binders and tracks trial milestones
Ensure the eTMF is being maintained up-to-date and all essential documents are appropriately filed in the eTMF
Collaborates with CROs to ensure accurate data collection and entry into the CTMS and EDC
Attend and contribute to team meetings, taking detailed meeting minutes
Supports clinical study management as delegated by Clinical Operations managers, including liaison with external vendors
Actively participates in process improvement initiatives to enhance clinical operations efficiency
All other duties as assigned
Qualification
Required
Bachelor's degree in biological sciences, health sciences or medical field, or equivalent combination of education and experience
2+ Years of experience in clinical study environment within CRO or Pharmaceutical company
Strong understanding of the phases of clinical drug development and clinical operation processes from start-up to close-out
Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines
Ability to organize, prioritize tasks, identify and resolve issues efficiently. Manage multiple tasks effectively and follow through on assigned tasks
Ability to receive general instructions on new assignments and perform routine work independently. Collaborate and work effectively within a team and within a multi-disciplinary environment
Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form
Attention to detail, accuracy and confidentiality
Critical thinking, problem solving, ability to work independently
Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader) and database software (eTMF, EDC) to support operation of clinical trial databases and electronic filing methods
Work in a fast-paced, demanding and collaborative environment
Demonstrate high ethical standards for honesty, truthfulness and integrity
Benefits
Bonus
Stock
Benefits
Other applicable variable compensation
Company
Summit Therapeutics, Inc.
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.
201-500 employees
H1B Sponsorship
Summit Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.79BKey Investors
CARB-XEurofarmaBiomedical Advanced Research and Development Authority (BARDA)
2025-10-21Post Ipo Equity· $500M
2024-09-11Post Ipo Equity· $235M
2024-06-03Post Ipo Equity· $200M
Leadership Team
Manmeet Soni
Chief Operating Officer and Board Member
Recent News
The Motley Fool
2026-01-13
Company data provided by crunchbase