Clinical Trial Associate

Clinical Trial Associate

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 sponsor ships.
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* NOTE:

We are not accepting resumes from agencies. ***