Clinical Trial Associate

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 Summits 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 Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology Summit has multiple global Phase 3 clinical studies including Non small Cell Lung Cancer NSCLC 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 TKIHARMONi 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 NSCLCHARMONi 7 Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first line metastatic NSCLCColorectal Cancer CRC 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 Chinas National Medical Products Administration NMPA Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland Overview of Role The Clinical Trial Associate CTAis responsible for supporting the daily workflow of clinical operations activities They will provide administrative support to study teams throughout the study

Key administrative activities include but are not limited to managing meeting invitations creating agendas and meeting minutes study document filing maintaining study trackers and oversight of the eTMFand vendors Role and Responsibilities Provides administrative support to the clinical operations study team including managing meetinglogistics creating agendas and drafting meeting minutes Executes tasks as assigned by the Clinical Operations Manager including study budget forecasting and tracking Ensuresaccurateandtimelydocumentation including eTMF management studycontractsand 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 andmaintainsstudy related materials such as country and site binders and tracks trial milestones Ensure the eTMF is beingmaintainedup to dateand all essential documents are appropriately filed in the eTMF Collaborates with CROs to ensureaccuratedata 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 Activelyparticipatesin process improvement initiatives to enhance clinical operations efficiency All other duties as assigned Experience Education and Specialized Knowledge and Skills Bachelors 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 tasksidentifyand 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 detailaccuracyand 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 paceddemandingand collaborative environment Demonstrate high ethical standards for…