Position Summary:
The Clinical Trial Associate (CTA) role supports clinical trial execution in Ph.D. 2 and Ph.D. 3 trials. This role may include working on multiple protocols with the potential to cross-train across different oncology indications using various clinical trial databases. A positive, can-do attitude is a must.
Essential Areas of Responsibility:
- Assist in auditing, collecting, and completing essential study-related activities, including data entry and uploading into various systems, including databases, CTMS, and eTMF
- Perform primary review of submitted clinical data, database entry, and source document verification according to established standard operating procedures (SOPs)
- Participate in reviewing and verifying data for quality control processes to ensure quality in documentation and archiving clinical data
- Assist in pathology slide management on select clinical studies, including database cleaning, sample organization, return shipment processing, managing sample storage, tracking, and accountability documentation. Pharma GLP and e-Safety training will be provided and is required
- Assist in the planning and organizing study-specific meetings and write and distribute regular updates.
- Serve as a primary point of communication between Candel and clinical sites and work with sites to ensure compliance with protocol and overall clinical objectives
- Review of monitoring reports, reconciliation of findings, upkeep of IRB submissions, and site invoicing. Under the direction of the CTM
- Maintain study-related trackers and systems that will support Clinical Operations and individual studies
- May participate in reviewing study-related templates, logs, plans, manuals, and ongoing personnel training
- Collaborate with external parties to complete study-related activities, such as site activation monitoring visits, training, etc
Minimum Education, Experience, and Skill Requirements:
Education:
- Bachelor’s degree (in a health-related discipline or similar is preferable).
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
- GCP certification, knowledge of 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 using standard office software: Microsoft Word, Excel, and PowerPoint
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