Clinical Reseach Associate

CLINICAL RESEARCH ASSOCIATE

Location: UK/EU

About Summit:

Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:

• HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).
• HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
• HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit\’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

Overview of Role:

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.

Role and 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

Experience, Education and Specialized Knowledge and Skills:

• Bachelor\’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
• A minimum of 3+ years of clinical research experience in conducting clinical trials
• Prior phase II or III experience required
• A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
• Experience with clinical studies oncology and / or rare diseases a plus
• 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
• Experience in working in a small organization a plus
• Excellent written and oral communication skills