Clinical Trial Associate

Summary:  

As a Clinical Trial Associate, you will play a key role in supporting the planning, execution, and management of clinical trials. You will assist in ensuring the successful conduct of clinical studies while adhering to regulatory requirements and internal procedures. Your attention to detail, organizational skills, and ability to work effectively within a team will contribute to the overall success of the clinical trial operations. 

Responsibilities: 

• Assist in the preparation and review of study-related documents, including protocols, informed consent forms, case report forms (CRFs), and study manuals. 
• Coordinate the collection, review, and tracking of essential study documents from participating sites, ensuring compliance with regulatory requirements. 
• Assist in obtaining regulatory and ethical committee approvals and maintaining documentation of the approval process. 
• Support the selection, initiation, and ongoing monitoring of clinical trial sites. 
• Maintain regular contact with study sites, providing support and addressing queries regarding study procedures, data collection, and regulatory compliance. 
• Assist in the coordination and organization of investigator meetings, training sessions, and site initiation visits. 
• Assist in the development and maintenance of study-specific data management tools and systems, ensuring data accuracy, completeness, and timeliness. 
• Perform periodic data review and query resolution to ensure data quality and integrity. 
• Assist in the tracking and reporting of study progress, including patient enrollment, data collection, and site monitoring visits. 
• Assist in the close-out of clinical trials, including the collection and review of study documents, site feasibility reports, and investigator final reports. 
• Ensure compliance with regulatory requirements, GCP guidelines, and internal standard operating procedures. 

Qualifications: 

• Bachelor's degree in life sciences, healthcare, or related field. 
• Prior experience in clinical research or clinical trial operations is preferred. 
• Knowledge of clinical trial processes, regulations, and GCP guidelines. 
• Familiarity with regulatory requirements from authorities such as the FDA, EMA, and ICH. 
• Excellent organizational and time management skills. 
• Strong written and verbal communication skills. 
• Proficiency in using clinical trial management systems (CTMS), electronic data capture (EDC) systems, and Microsoft Office applications. 
• Ability to work both independently and collaboratively in a team environment. 
• Strong problem-solving and critical-thinking abilities.