Clinical Trial Associate

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

Education Minimum Education, Experience and Skill Requirements

• Minimum 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.
• Skills: 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. Ability 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.
• Other: Must be authorized to work in US. We cannot provide sponsorships.