Clinical Trial Associate

Needham, MA
Full Time
Mid Level
  • Location: Hybrid, Needham, MA 

  • Salary:  $88k-$100k  

Why Work With Us?   
At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. Like a team, we show up for each other and stay focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability, encouraging ownership and innovation every day.   

Our Science: Advancing Cancer Immunotherapies   
Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it’s an exciting time to join us and help bring transformative cancer treatments to patients. Learn more: www.candeltx.com   

Position Summary: 

The Clinical Trial Associate (CTA) role supports clinical trial execution in Ph 2 and Ph 3 trials. This role includes working on multiple protocols with the potential to cross-train across different oncology indications using a variety of clinical trial databases. 

Essential Areas of Responsibility: 

  • Execute and support day-to-day clinical trial operations in alignment with protocols, timelines, and regulatory requirements.  

  • Participate in reviewing, formatting, and finalizing study-related templates, logs, plans, and manuals and ongoing training of personnel. 

  • Assist in collecting and completing essential study-related activities, including data entry into multiple databases. 

  • Ensure the quality of data submitted from assigned study tasks and timely data submission, including appropriate progress reporting. 

  • Manage imaging vendor and maintain tracking of invoices, sample delivery and recovery from the vendor site. 

  • Assist in the planning and organizing study-specific meetings and write and distribute regular updates. 

  • Assist the Clinical Trial Manager in select site management activities. This could include a review of monitoring reports and source document review. 

  • Maintain study-related trackers that will support Clinical Operations and individual studies. 

  • Perform primary review of submitted clinical data, database entry, and source document verification according to established standard operating procedures (SOPs). 

  • participate in the review and verification of data for quality control processes. 

  • Ensure quality in documentation and archiving of clinical data. 

  • Support invoice tracking, purchase order coordination, and budget-related activities for study. 

Minimum Education, Experience and Skill Requirements: 

Education: 

  • Bachelor’s degree in a health-related discipline or similar.  

Experience: 

  •  At least 2 years of experience in the clinical research/pharmaceutical/biotech arena and an understanding of clinical research and the requirements of a clinical operations function. 

  • Excellent verbal and written communication skills, good organizational and interpersonal skills, and team drive. 

  • Knowledge of GCP and FDA regulations related to clinical trial conduct and familiarity with industry best practices. 

  • Able to manage multiple projects independently and use varying databases and management systems. 

  • Discretion in handling confidential information. 

  • Knowledge of project management tools and practices and proficiency in using normal office software: Microsoft Word, Excel, and PowerPoint. 

Must be authorized to work in US. We cannot provide sponsorships. 
 
*** NOTE: We are not accepting resumes from agencies. *** 

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