Clinical Research Associate

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Location:
On-Site 4 days per week at our Princeton, NJ or Miami FL locations

About Summit:

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people.

Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:

• HARMONi:
  Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
• HARMONi-3:
  Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
• HARMONi-7:
  Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
• HARMONi-GI3:
  Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

The Clinical Research Associate (CRA) is responsible for supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial.

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…