About C4 Therapeutics
C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients' lives. C4T is leveraging its TORPEDO platform to efficiently design and optimize small-molecule medicines that harness the body's natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. C4T is advancing multiple targeted oncology programs to the clinic and expanding its research platform to deliver the next wave of medicines for difficult-to-treat diseases. For more information, please visit www.c4therapeutics.com
C4 Therapeutics is seeking a highly talented and experienced Senior Clinical Trial Associate (CTA) to support the Clinical Operations department in the planning, execution, and management of in-house or outsourced clinical trials. The Sr. CTA will support the clinical trial team, ensuring that all essential documentation is collected, maintained, and filed during the study. The Sr. CTA will also assist the Clinical Operations Study Lead for assigned studies and maintain focus on intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMA, GCP, and ICH guidelines. This position reports to the Associate Director of Clinical Operations. Up to 10% domestic travel may be required.
Support Clinical Operations Study Lead with clinical trial activities, including oversight of outsourced activities to Clinical Research Organizations (CRO) and other third-party vendors
Execute assigned operational tasks, assist in tracking study metrics, maintain and distribute study trackers
Assist in the coordination and tracking of clinical supply shipments, equipment, and study-specific laboratory samples
Interact with clinical trial sites to foster relationships and support collection of relevant study materials/ documentation
Support Clinical Operations Study Lead in collection, tracking, and maintenance of clinical trial documentation and regulatory documents for the electronic Trial Master File (eTMF)
Review TMF documents for completeness, accuracy, and compliance with protocol and appropriate regulations as part of the quality review process; acts as primary liaison with the CRO to collect trial documents and coordinate review of the eTMF to ensure inspection-readiness at all times; Identify issues and take appropriate corrective action
Assist in the preparation of study related documents (i.e. ICF, clinical trial tools, templates, training materials, manuals, study newsletters, etc.)
Support project meeting logistics such as: calendar management, room & equipment set up, collation of materials, and attendance tracking. Under the direction of the Clinical Operations Study Lead, prepare meeting agendas and a draft of meeting minutes
Coordinate the logistical aspects of vendor and investigator meetings
Develop and maintain financial trackers for each study to track vendor invoices, Purchase Order balances, facilitate Clinical Operations Study Lead review and approval of all vendor invoices, and reconcile inconsistencies, as needed
Bachelor's degree in life/health sciences or healthcare-related field
2-5 years of experience in development experience, preferably in oncology clinical operations at a pharmaceutical company, biotech company, and/or CRO
Working knowledge of ICH GCP regulations and clinical protocols
Strong computer skills including knowledge of Smartsheets, Excel, Word, PowerPoint, SharePoint, Veeva, and Outlook
Excellence interpersonal, organizational, and multi-tasking skills
Sound analytical and problem-solving skills; ability to act with a consistent sense of urgency
Demonstrated effectiveness in resolving site management issues of varying complexity
Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
Must be able to professionally interact and communicate with visitors, vendors and individuals at all levels of the organization
Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
Excellent written and verbal communication skills
Team player that takes initiative and is willing to support optimizing the way we work
Collaborates and communicates in an open and clear manner, listening effectively and inviting response and discussion, including with other internal partners, CROs, and other external service providers
Comfortable in a fast-paced, results-driven, highly accountable environment with large potential impact.
C4 Therapeutics is an Equal Opportunity Employer.
C4 Therapeutics is committed to creating a safe and healthy workplace. In order to ensure the safety and health of our employees, C4 Therapeutics requires all new employees to be fully vaccinated against COVID-19 upon the start of their employment, unless they obtain prior approval for an accommodation for medical reasons or due to a sincerely held religious belief or are exempt from this requirement under applicable state or local law. Qualified candidates who are offered the opportunity to join C4 Therapeutics will be required to provide proof of vaccination during the onboarding process.
C4 Therapeutics, Inc.