Clinical Research Associate

Location:

On‑site 4 days per week at our Princeton, NJ or Miami, FL locations.

Summit Therapeutics Inc. is a biopharmaceutical oncology company dedicated to improving the quality and duration of life for patients and resolving serious unmet medical needs. We build a world‑class team driven by integrity, passion, collaboration and a commitment to people.

The CRA supports all aspects of Clinical Trial Management for complex, global studies from planning and start‑up through close‑out. The role collaborates with functional team members, CROs, vendors and sites to deliver high‑quality data under the direction of a Clinical Trial Manager or Director.

• Communicate with project team and sites to ensure training, understanding of milestones and deliverables.
• Review, approve and track vendor invoices; manage accruals and payment processes for clinical trial vendors including investigational sites.
• Build professional relationships with clinical site staff.
• Partner with the CRO to implement robust data monitoring strategies and ensure high‑quality data delivery.
• Create and maintain study trackers.
• Document meeting minutes, action items and closures for assigned study meetings.
• Develop and manage clinical trial documents such as consent forms, site welcome packets and study binders.
• Review and comply with study plans, processes, agreements and guidelines.
• Request and log CRO/vendor RFIs, RFPs, contracts, work orders and specifications.
• Approve essential document packages for timely site activations.
• Track Monitoring Report reviews to ensure compliance and documentation completeness.
• Provide oversight of monitoring findings and coordinate updates with the broader team.
• Support investigator performance guidance and address protocol adherence, conduct issues and enrollment problems.
• Maintain the Trial Master File (TMF) and perform periodic quality control.
• Ensure compliance with Good Clinical Practice, national regulatory requirements and company SOPs.
• Keep the study inspection‑ready at all times.
• Support and train other CRAs on the project as needed.
• Perform all other duties as assigned.

• Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology or related area (preferred).
• Minimum 3+ years of clinical research experience, with phase II or III experience required.
• Solid understanding of recruitment methods, drug development, ICH guidelines/GCP and all trial phases.
• Experience with oncology or rare disease studies is a plus.
• Proficiency in Microsoft Outlook, Word, Excel and Teams.
• Travel internationally to visit sites and attend study meetings (up to 20%).
• Strong interpersonal, communication and decision‑making skills.
• Ability to build relationships with KOLs and site personnel, and to support patient enrollment strategies.
• Excellent planning, time‑management and coordination skills.
• Problem‑solving ability and sound judgment regarding regulatory requirements and complex programs.
• Experience working in a small organization is a plus.

Pay range: $97,000 – $114,000 annually. Compensation may include bonus, stock, benefits and other variable components.

Summit does not accept referrals from employment businesses or agencies unless authorized by the Talent Acquisition team.