Summit Therapeutics, Inc. · 1 day ago
Clinical Research Associate
Princeton, NJ
Full-time
Onsite
Mid Level
$97K/yr - $114K/yr
3+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. The Clinical Research Associate (CRA) is responsible for supporting all aspects of Clinical Trial Management for complex, global studies, collaborating with team members and vendors to ensure successful delivery of clinical studies.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables
Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites
Initiates and builds solid professional relationships with clinical site staff
Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data
Creation and development of study trackers
Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings
Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc
Responsible for reviewing assigned study related plans, processes, agreements, and guidelines
Following and implementing assigned study related plans, processes, agreements, and guidelines
Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met
Reviews and approves essential document packages to enable timely site activations
Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete
Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed
Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF
Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
Ensures the study is 'inspection ready' contemporaneously
Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate
All other duties as assigned
Qualification
Required
A minimum of 3+ years of clinical research experience in conducting clinical trials
Prior phase II or III experience
A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams
Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)
Tenacity to work in a fast-paced team environment
Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships
Ability to successfully engage and work collaboratively with global team members/colleagues
Ability to support building and delivery of patient enrolment strategies
Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives
Ability to review and assess clinical data
Possesses excellent planning, time management & coordination skills
Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
Excellent written and oral communication skills
Preferred
Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area
Experience with clinical studies oncology and / or rare diseases
Experience in working in a small organization
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