Clinical Research Associate

Responsibilities

• Prepare study related documents for the study sites IRB submission& or related submission according to the regulation/ site requirements.
• Conduct site selection, contract & budget communication, study site initiation, monitoring work, safety events reporting, and close-out visits in accordance with the study protocol, contracted scope of work, SOPs, and regulation& research institution requirements.
• Manage monitoring activities across multiple protocols, study sites, and therapeutic areas concurrently.
• Provide protocol and study-related training to assigned sites, and maintain regular communication to address ongoing project requirements and issues.
• Evaluate the quality and integrity of site performance to ensure studies are conducted in compliance with the protocol and applicable regulations.
• Escalate any outstanding issues as needed to the assigned CPM and/or line manager and follow them up till appropriate resolution
• Track IRB/IEC review and approval, subject enrollment, CRF completion and submission, as well as data query generation and resolution to manage site progress.
• Create and maintain documentation related to site management, monitoring findings, and action plans; submit monitoring visit reports and other required study documents within timeline.
• Handle study financial management for assigned sites.
• Handle trial devices as needed.
• Keep close communication with related investigator to assure smooth and efficient process at the site level.
• Communicate with trial related 3rd parties to assure study timeline, quality and issues are well managed and resolved in a timely manner according to the trial requirements.
• Collaborate effectively with cross-functional teams to assure efficiency of study process.
• Perform other duties as assigned by the line manager and/or project manager.

Requirements

• Bachelor's degree or above in life sciences or equivalent.
• Eligible to work in the United States without visa sponsorship.
• With 3+ years of on-site monitoring experience in the medical device industry, cardiovascular related preferred
• Good knowledge of clinical research and understanding of applicable regulatory requirements.
• Proficient in medical device clinical research local regulatory requirements, ISO 14155 and clinical systems.
• A good communicator, problem-solver, and team player.
• Willing and able to travel frequently.
• Demonstrate effective intercultural Communication skills and eager to learn
• Native English speaker or professional English level.