Clinical Trial Associate

Needham, MA

Full Time

Mid Level

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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Clinical Trial Associate

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