Job Description
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:
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 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.
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
This is the pay for this position
Pay Transparency
$115,000-$125,000 USD
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 Summit's Talent Acquisition team at [click to reveal email address] recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Job Tags
Full time