- Location:Hybrid, Needham, MA
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. *** 
