Clinical Trial Associate

About Candel Therapeutics

Candel Therapeutics operates from Needham, MA, focusing on creating innovative cancer immunotherapies. This clinical-stage biopharma company specializes in developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor immune responses, utilizing genetically modified adenovirus and HSV platforms. With successful Phase 3 clinical results for their primary candidate, the company fosters a mission-driven culture of diversity, collaboration, and empowerment designed to innovate and impact patient care.

Role Overview

The Clinical Trial Associate (CTA) is instrumental in supporting clinical trial execution across Phase 2 and Phase 3 studies. The role covers multiple protocols and offers opportunities to gain exposure across various oncology indications and clinical trial database systems.

Key Responsibilities

• Execute and manage daily clinical trial operations in strict compliance with protocols, timelines, and regulatory standards.
• Engage in reviewing, adapting, and finalizing study templates, logs, plans, and manuals, as well as training staff continually.
• Assist in the collection and completion of critical study tasks, including data entry into various databases.
• Maintain the accuracy and timely submission of clinical data, including progress reports.
• Oversee imaging vendor relationships, invoice tracking, shipment, and sample recovery processes.
• Help plan and organize study meetings, compose updates, and distribute information regularly.
• Support Clinical Trial Manager by assisting with site management functions such as monitoring report evaluations and source document reviews.
• Maintain clinical study trackers supporting both individual studies and overall clinical operations.
• Conduct primary review of submitted clinical data, database entry, and source verification per SOPs.
• Participate in data verification and quality control processes to ensure data integrity.
• Ensure meticulous documentation and archiving of clinical data.
• Support budget-related tasks including invoice tracking and purchase order coordination.

Candidate Requirements

• Bachelor’s degree in a health-related field or comparable discipline.
• Minimum of 2 years' relevant experience within clinical research, pharmaceutical, or biotech settings, understanding clinical operations' regulatory environments.
• Strong verbal and written communication capabilities, organizational skills, team collaboration, and motivation.
• Working knowledge of Good Clinical Practice (GCP), FDA regulations on clinical trials, and contemporary industry standards.
• Capability to independently manage multiple projects and proficiency with diverse databases and management systems.
• Ability to handle confidential information with discretion.
• Familiarity with project management methodologies and competent use of MS Word, Excel, and PowerPoint.
• Authorization to work in the United States is mandatory; sponsorship is not available.

Additional Information

Applicants are advised that resumes submitted through staffing agencies will not be considered.

Compensation and Location

• Position location is hybrid at Needham, MA.
• Annual salary range: $88,000 to $100,000.