Clinical Project Assistant
Clinical Project Assistant
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 (e.g. osimertinib).
HARMONi-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 NSCLC.
HARMONi-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 Project Assistant (CPA) provides administrative and operational support to the Clinical Operations team including site contracting and clinical site partnership functions. This role plays a key part in ensuring smooth coordination across study start-up site engagement and ongoing trial activities. The CPA works closely with Clinical Operations staff contract management personnel and site-facing teams to support the timely execution and maintenance of clinical trials.
Role and Responsibilities:
- Support Clinical Operations staff with administrative and operational tasks related to study planning start-up conduct and close-out.
- Assist with the coordination and tracking of site contracting and budget negotiation activities including the collection and organization of contract documents and approvals.
- Maintain tracking tools and databases for site activation status contract progress site performances data and document submissions.
- Provide support to the Clinical Site Partner team by coordinating site communications assisting with outreach logistics and ensuring timely follow-up on site requests and issues.
- Provide support where needed with the Trial Master File (TMF) ensuring compliance with GCP ICH guidelines and internal SOPs.
- Support audit and inspection readiness efforts through document quality checks and TMF maintenance.
- Assist in the preparation and scheduling of internal and external meetings including developing agendas taking meeting minutes and tracking action items.
- Support department training efforts
- Help develop and maintain study-specific tools such as trackers logs templates and site contact lists.
- Contribute to process improvement initiatives across Clinical Operations and site management functions.
- All other duties as assigned
Experience Education and Specialized Knowledge and Skills:
- Bachelors degree in Life Sciences Business Administration or related field required
- Understanding of clinical trial processes GCP and regulatory documentation is preferred.
- Strong organizational and time-management skills with high attention to detail.
- Effective written and verbal communication skills.
- Proficient in Microsoft Office (Word Excel Outlook PowerPoint); familiarity with clinical trial management systems (CTMS) or document management platforms is a plus.
- Ability to work collaboratively in a cross-functional fast-paced environment.
- Critical thinking problem solving ability to work independently
- Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
- Prioritize conflicting demands
- Work in a fast-paced demanding and collaborative environment
- Knowledge of GCP guidelines and relevant regulatory requirements
Employment Type
Contract
