-Bachelor degree or above, at clinical medicine or related; -Knowledge of S/FDA regulatory requirements and ICH/GCP guidelines essential; -One year’s experience in clinical operations; -Good communication skills, and attention at details, information analyzing; -Good team spirits; -Ability to work under pressure and travel;ponsibilities: -To conduct clinical monitoring activities in accordance with SOPs, S/FDA regulations, and ICH/GCP guidelines, including site selection, IRB submission, and routine monitoring activities (such as source data verification, investigational products and other supplies management.); -To report study status through monitoring report and meeting; -To Assist Project Manager with preparation of study payment; -To identify, analyze and resolve (assist with Project Manager) issues may occur at site; -To maintain Trial Master File as required;
-Bachelor degree or above, at clinical medicine or related; -Knowledge of S/FDA regulatory requirements and ICH/GCP guidelines essential; -One year’s experience in clinical operations; -Good communication skills, and attention at details, information analyzing; -Good team spirits; -Ability to work under pressure and travel; Key Responsibilities: -To conduct clinical monitoring activities in accordance with SOPs, S/FDA regulations, and ICH/GCP guidelines, including site selection, IRB submission, and routine monitoring activities (such as source data verification, investigational products and other supplies management.); -To report study status through monitoring report and meeting; -To Assist Project Manager with preparation of study payment; -To identify, analyze and resolve (assist with Project Manager) issues may occur at site; -To maintain Trial Master File as required; Requirements: -Bachelor degree or above, at clinical medicine or related; -Knowledge of S/FDA regulatory requirements and ICH/GCP guidelines essential; -One year’s experience in clinical operations; -Good communication skills, and attention at details, information analyzing; -Good team spirits; -Ability to work under pressure and travel;
职位要求:- Bachelor’s degree; BSM, RN or BSN preferred - Three or more years’experience in clinical operations; - Monitoring experience a plus - Knowledge of S/FDA regulatory requirements and ICH/GCP guidelines essential - Demonstrated understanding and good use of judgment in application of regulations to clinical trial implementation and conduct - Computer proficiency (Windows preferred, including Word, Excel, PowerPoint, Outlook) - Flexible; adapts work style to meet organization needs - Works proactively and effectively in a fast-paced, high change environment - Excellent oral and written communication skills - Known as a strong contributor in high performing teams - Ability to develop collaborative internal and external relationships - Ability to identify issues and problems to management - Outstanding organizational skills with an eye for detail - Dedicated to quality, reliability, and excellence in all work tasks - Perspective is on study level; independently sets short and long-term goals based on study timelines and manager guidance - Able to travel approximately 20-30%of the time (domestic
职位要求:Qualifications 1. Bachelor’s degree in arelevant field (i.e., nursing, medicine, public health), or equivalentexperience. 2. Computer skillsrequired. 3. Strongcommunication skills. 4. Ability tomulti-task. Other 1. Must residein the area where the clinical trial is being conducted for the duration on thetrial. 2. Positionrequires often national travel. 3. Strong reading andwritten skills in English
职位要求: Qualifications 1. Bachelor’s degree in arelevant field (i.e., nursing, medicine, public health), or equivalentexperience. 2. 1-2 yearsprevious experience in clinical related work. 3. Computerliteracy required. 4. Strongleadership and communication skills. 5. Ability tomulti-task. 6. Familiarityof GCP. 7. Previousexperience with multi-partner conduct of clinical trials and project managementpreferred. 8. Familiarityof electronic data capture systems. 9. Familiarityof IW/VR systems. 10. Haveexperience with dealing with central lab (sample handling) Other 1. Must residein the area where the clinical trial is being conducted for the duration on thetrial. 2. Positionrequires often national travel. 3. Strong reading andwritten skills in English.