Clinical Trial Associate

About the Company and Role

Candel is a clinical-stage biopharmaceutical company dedicated to developing off-the-shelf, multimodal immunotherapies designed to activate personalized, systemic anti-tumor responses, primarily using genetically modified adenovirus and HSV constructs. Following successful Phase 3 trial results for their lead drug candidate, the company is positioned for growth and impactful work in oncology.

This Clinical Trial Associate (CTA) role is integral in supporting clinical trial activities, particularly for Phase 2 and Phase 3 oncology trials. The position involves multitasking across various protocols and offers the chance to gain experience in multiple oncology indications and utilize different clinical trial databases.

Key Responsibilities

• Support daily operations of clinical trials ensuring compliance with protocols, established timelines, and regulatory standards.
• Assist in reviewing and finalizing study documents such as templates, logs, plans, and manuals, and contribute to ongoing personnel training.
• Participate in data collection activities and perform data entry across multiple clinical trial databases.
• Maintain high data quality by verifying timely and accurate data submission and preparing progress reports.
• Oversee imaging vendor management, including invoice tracking and sample logistics.
• Help organize study meetings and disseminate regular updates to stakeholders.
• Support the Clinical Trial Manager in site management tasks such as reviewing monitoring reports and source documents.
• Maintain and update study trackers supporting clinical operations and individual studies.
• Conduct primary reviews of clinical data submissions, ensure database accuracy, and perform source document verification in line with SOPs.
• Engage in data quality control reviews and ensure proper documentation and archival of clinical trial information.
• Assist with financial tracking related to invoices, purchase orders, and budget coordination for studies.

Qualifications and Experience

• Possess a Bachelor’s degree in a health-related field or an equivalent discipline.
• Minimum of two years’ professional experience in clinical research, pharmaceuticals, or biotechnology, with a solid understanding of clinical operations.
• Strong written and verbal communication abilities, excellent organizational aptitude, interpersonal skills, and team collaboration orientation.
• Familiarity with Good Clinical Practice (GCP), FDA regulations on clinical trials, and prevailing industry standards.
• Capability to independently manage multiple projects using various databases and clinical management systems.
• Ability to handle confidential information with discretion.
• Proficiency in project management tools and common office software including Microsoft Word, Excel, and PowerPoint.

Additional Information

• Location: Hybrid work arrangement based in Needham, Massachusetts.
• Salary range: $88,000 to $100,000 annually.
• Must be authorized to work in the United States; sponsorship is not provided.
• Resumes from recruitment agencies are not being accepted.

Company Culture: Candel fosters an inclusive and mission-driven environment valuing diversity, trust, innovation, flexibility, and accountability. Leadership promotes transparency and encourages ownership and collaboration among team members, all contributing to making a significant difference for patients and their families.