Clinical Research Associate II

Location On Site 4 days per week at ourMenlo Park CA Princeton NJ or Miami FL office 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 eg osimertinibHARMONi 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 NSCLCHARMONi 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 Summits 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 deliverablesReviewapprovetrack vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sitesInitiates and builds solid professional relationships with clinical site staffPartners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high quality dataCreation and development of study trackersDevelop and provide clear complete documentation of study specific meetings action items and action item closure for assigned study meetingsResponsible for the development and management of clinical trial documents including but not limited to consent documents site welcome packets study binders etcResponsible for reviewing assigned study related plans processes agreements and guidelinesFollowing and implementing assigned study related plans processes agreements and guidelinesResponsible for requesting and logging CRO and vendor RFIs RFPs contractswork orders and specifications to enable study objectives to be metReviews and approves essential document packages to enable timely site activationsConducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is completeProvides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as neededAssess and support investigator performance guidance and adherence to protocol and proactively addresses conduct issues and enrollment problems as necessaryResponsible for oversight on the maintenance of the TMF and completeness at the end of the study Perform periodic QC of the TMFOversee 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 SOPsEnsures the study is inspection ready contemporaneouslyResponsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriateAll other duties as assignedExperience Education and Specialized Knowledge and Skills Bachelors degree or equivalent in life science nursing pharmacy medical laboratory technology or other healthmedical related area preferredA minimum of 3 years of clinical research experience in conducting clinical trialsPrior phase II or III experience requiredA solid understanding of the recruitment methods drug development process ICH guidelinesGCP and specifically each step within the clinical trial processExperience with clinical studies oncology and or rare diseases a plusSophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook Word Excel and TeamsAbility to travel internationally to visit clinical sites and for study meetings Amount will vary upon project needs up to 20Tenacity to work in a fast paced team environmentEnjoys building relationships with KOLs and site personnel Willing to travel to establish relationshipsAbility to successfully engage and work collaboratively with global team memberscolleaguesAbility to support building and delivery of patient enrolment strategiesExcellent interpersonal and decision making skills Demonstrates innovation possesses drive energy and enthusiasm to deliver the program objectivesAbility to review and assess clinical dataPossesses excellent planning time management & coordination skillsDemonstrated ability to problem solve and use clear judgment in relation to regulatory requirements interactions with external parties timelines and complex clinical programsExperience in working in a small organization a plusExcellent written and oral communication skillsThe pay range for this role is 113500 to 133000 annually Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location This may be different in other locations due to differences in the cost of labor The total compensation package for this position may also include bonus stock benefits andor other applicable variable compensation Summit does not accept referrals from employment businesses andor employment agencies in respect of the vacancies posted on this site All employment businessesagencies are required to contact Summits Talent Acquisition team atrecruitingsmmttxcomto obtain prior written authorization before referring any candidates to Summit