Clinical Trial Associate
About The Position
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. The Clinical Trial Associate (CTA) is 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 eTMF and vendors.?
Requirements
- 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 tasks, identify and 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 detail, accuracy and 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-paced, demanding and collaborative environment
- Demonstrate high ethical standards for honesty, truthfulness and integrity
Responsibilities
- Provides administrative support to the clinical operations study team, including managing meeting logistics, creating agendas, and drafting meeting minutes
- Executes tasks as assigned by the Clinical Operations Manager, including study budget forecasting and tracking
- Ensures accurate and timely documentation, including eTMF management, study contracts and 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 and maintains study-related materials, such as country and site binders and tracks trial milestones
- Ensure the eTMF is being maintained up-to-date and all essential documents are appropriately filed in the eTMF
- Collaborates with CROs to ensure accurate data 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
- Actively participates in process improvement initiatives to enhance clinical operations efficiency
- All other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
