Clinical Research Associate

Location: On-Site 4 days per week at ourPrinceton 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 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.

Colorectal 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 Research Associate(CRA)isresponsible forSupporting all aspects of Clinical Trial Management for complex global studies from study planning and start up through study close role will collaborate withfunctional team members CROsand vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or CRAis responsible foradherenceto 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

• Creationand developmentof study trackers

• Develop and provide clear complete documentation of study-specific meetings actionitemsand 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 studyobjectivesto be met

• Reviews and approves essential document packages to enabletimelysite 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 andenrollmentproblems 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 activitiesin accordance withGood 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 Associatesallocatedto the project through leadership and training as indicated and appropriate

• All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

• Bachelors degree or equivalent in life science nursing pharmacy medical laboratory technology or other health/medical related area preferred

• A minimum of 3years of clinical research experience in conducting clinical trials

• Prior phase II or III experiencerequired

• 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 highlyskilfulutilizationof 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 toestablishrelationships

• Ability to successfully engage and work collaboratively with global team members/colleagues

• Ability to support building and delivery of patientenrolmentstrategies

• Excellent interpersonal anddecision-makingskills. Demonstrates innovationpossessesdriveenergyand enthusiasm to deliver the programobjectives.

• 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

The pay range for this role is $97000-$114000 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 and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.